Application for the Reassessment of a Group of … 400EC HSR000956 Page 10 Decision on the Application for reassessment of OPC plant protection insecticides (APP201045) June 2013 Fenafos

DECISION

www.epa.govt.nz

7 August 2015 – a modified reassessment was undertaken. Please see APP202142. 21 July 2015 – amended under section 67A of the HSNO Act 2 July 2014 – amended under section 67A of the HSNO Act 27 June 2013 – original approval

Application for the Reassessment of a Group of Hazardous Substances under Section 63 of the Hazardous Substances and New Organisms Act 1996 27 June 2013

APP201045: Active ingredients and/or formulated substances containing:

Acephate, Benomyl, Carbaryl, Carbofuran, Carbosulfan, Chlorpyrifos, Chlorpyrifos-methyl, Diazinon, Dichlorvos, Dichlofenthion, Dimethoate, Ethion, Famphur, Fenamiphos, Fenitrothion, Isazofos, Maldison (Malathion), Methamidophos, Methomyl, Omethoate, Oxamyl, Phorate, Phoxim, Pirimicarb, Pirimiphos-methyl, Prothiofos, Pyrazophos and Terbufos

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Decision on the Application for reassessment of OPC plant protection insecticides (APP201045)

June 2013

Chair’s introduction

General – use and effects of organophosphates and carbamates in New

Zealand

Organophosphates and carbamates (OPCs) are insecticides that have been widely used in New

Zealand and internationally for many decades against a broad range of insect pests for a variety of

purposes (plant protection, veterinary medicine, public health and industrial uses). This

reassessment relates to the use of OPCs for plant protection purposes.

OPCs play a key role in New Zealand as part of our agricultural pest management programmes for

the horticultural, grass/pastoral and ornamental sectors. OPCs are also used for biosecurity purposes

to control and/or eliminate insects, pests and pathogens from live plant material entering New

Zealand or being cleared at the border.

OPCs affect the nervous system by inhibiting the enzyme acetylcholinesterase which leads to

overstimulation of the nervous system. Of the two groups of substances organophosphates have a

longer lasting effect on the nervous system than carbamates.

OPCs are also harmful to the environment being very toxic to aquatic life and to terrestrial

invertebrates, and in general they are also toxic to birds.

This reassessment

This reassessment has been extremely complex and time-consuming for all involved. It has taken

several years to get to this point. The reassessment programme for OPCs started with reassessing

acephate, diazinon, dichlorvos and methamidophos. However, the EPA decided that it was more

appropriate, efficient and cost effective for all concerned to reassess the substances as a whole to

ensure not only safe management of such substances but also to ensure that the suite of tools

available for plant protection and biosecurity was not seriously undermined.

The process

Once the initial consultation phases had been completed the Committee held hearings in two

locations (Wellington and Auckland) to hear from submitters. The Committee wishes to thank the

submitters who have taken the time to make submissions both in writing and orally and the EPA staff

for their technical and administrative assistance throughout the process.

The outcome

The Committee has made a decision which attempts to strike the appropriate balance between

allowing the continued use of OPCs for commercial plant protection purposes whilst ensuring that the

most serious effects are appropriately avoided or managed. In general the Committee has decided

that OPC use in the home garden situation by unqualified users ought not to continue due to the

health effects for users and visitors. For substances critical to the agricultural sectors, their use

should be allowed to continue with additional controls imposed to ensure such uses are properly done

to manage the risks to people’s health and the environment.

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Final comments

As noted this has been a very complex and time-consuming task and the Committee is very mindful of

the importance of this decision to all New Zealanders. There is a phase-in period for all the changes

to allow time for a change in approach and practice to occur. The Committee has made a number of

recommendations regarding this period and in relation to research and other matters that it will be

asking the EPA to report back on over the coming years.

Helen Atkins

Chair, Organophosphate and carbamate plant protection insecticide reassessment committee of the

Environmental Protection Authority

27 June 2013

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Overview of the reassessment process

Grounds Application – Grounds approved 26/10/12

Grounds must be established in order for an application for a reassessment to be

lodged. An application for grounds is lodged with the EPA and is heard by an

independent decision making committee established under HSNO.

Reassessment Application – Notified for public consultation

02/11/12 – 22/01/13

Once grounds have been established, an application for a reassessment is

lodged and notified for public consultation.

Evaluation and Review Report – Circulated 18/02/13

After receipt of submissions on the application/consultation report, EPA Staff

prepare an evaluation and review report taking into account information that has

been submitted. This will be considered by the decision making committee.

Decision

After a public hearing and consideration of the application, the decision making

committee will issue its final decision.

This is the Decision document.

Public hearing – 04/03/13 and 07/03/13

Once EPA Staff have evaluated the submissions a public hearing is held, where

submitters can speak to the decision making committee.

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Table of Contents

Chair’s introduction ............................................................................................................................... 2

Overview of the reassessment process .............................................................................................. 4

1. Summary of decision................................................................................................................... 6

2. Background ................................................................................................................................ 13

3. The Reassessment of OPC plant protection insecticides ..................................................... 16

4. Sequence of the consideration ................................................................................................ 27

5. Treaty of Waitangi (Tirito ō Waitangi) ...................................................................................... 28

6. The substances .......................................................................................................................... 30

7. Hazard classifications ............................................................................................................... 31

8. Acceptable Daily Intakes ........................................................................................................... 32

9. Current management regime .................................................................................................... 36

10. Key sectors for use of OPC plant protection insecticides .................................................... 38

11. Assessment of benefits ............................................................................................................ 41

12. Assessment of adverse effects ................................................................................................ 47

13. International obligations ........................................................................................................... 56

14. Revised management regime ................................................................................................... 57

15. Overall evaluation of significant adverse and positive effects ............................................. 72

16. Recommendations ..................................................................................................................... 78

17. Decision ...................................................................................................................................... 79

Appendix A: Substances considered in the reassessment ............................................................. 83

Appendix B: Classifications of the approvals under consideration ............................................... 89

Appendix C: Acceptable daily intake/Potential daily exposure for food values for OPC active

ingredients ............................................................................................................................................ 98

Appendix D: Overview of risks and benefits for OPCs .................................................................... 99

Appendix E: Additional controls for plant protection insecticides containing OPCs ................ 120

Appendix F: Names of those who made oral presentations at the hearings ............................... 124

Appendix G: Decision path for the reassessment of OPC plant protection insecticides .......... 125

Appendix H: Abbreviations and acronyms ..................................................................................... 132

Annex: Controls for OPC plant protection insecticides ................................................................ 134

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June 2013

1. Summary of decision

Application code APP201045

Application type To reassess a group of hazardous substances under section 63A of

the Hazardous Substances and New Organisms Act 1996 (“the Act”)

Applicant The Chief Executive of the EPA

Purpose of the application To reassess a group of organophosphate and carbamate based

insecticides used for plant protection purposes

Date application received 1 November 2012

Submission period 2 November 2012 – 22 January 2013

Submissions received 36 submissions were received

Hearing dates and locations 4 March 2013, Environment Court, Wellington

7 March 2013, Holiday Inn Auckland Airport, Auckland

Considered by

A decision- making committee of the Environmental Protection

Authority (EPA):

Helen Atkins (Chair)

Val Orchard

Deborah Read

Damian Stone

Kevin Thompson

Decision

Approved with controls Approval code

Acephate (active ingredient) HSR002724

Soluble concentrate containing

195 g/litre acephate. Also

contains ethylene glycol1

HSR000154

Water soluble powder containing

750 - 970 g/kg acephate HSR000155

Emulsifiable concentrate

containing 45 g/litre acephate

and 8.8 g/litre myclobutanil

HSR000156



and 39 g/litre triforine

HSR000157


containing 22.5 g/litre acephate

and 19.5 g/litre triforine

HSR000158

1 Known trade names for the substances are listed in Appendices A and B

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June 2013

Wettable powder containing 150 -

200 g/kg carbaryl and 150 - 200

g/kg mancozeb

HSR007696

Suspension concentrate

containing 100 g/litre carbaryl HSR000441


containing 500 g/litre carbaryl

(Substance A)

HSR000450

Wettable powder containing 115

g/kg carbaryl, 250 g/kg copper as

copper oxychloride and 284 g/kg

sulphur

HSR000594



(Substance C)

HSR000680



(Substance B)

HSR000681

Granular material containing 100

g/kg chlorpyrifos HSR000163


g/kg chlorpyrifos HSR000165


g/kg chlorpyrifos. Also contains

xylene

HSR000170


containing 480 g/litre chlorpyrifos HSR000171

Wettable powder containing

56.25 g/kg carbendazim, 93.75

g/kg chlorpyrifos and 400 g/kg

mancozeb

HSR000173


containing 450 - 500 g/litre

chlorpyrifos

HSR000224


containing 480 g/litre chlorpyrifos.

Also contains xylene

HSR000225

Solid containing 50 - 55 g/kg

chlorpyrifos HSR007698

Liquid containing 250 - 350 g/litre


Rampage HSR100018

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Chlorpyrifos-methyl (active

ingredient) HSR004064


chlorpyrifos methyl HSR100326



DDVP insecticide strip HSR000126

J72.03 HSR001757

Dimethoate (active ingredient) HSR002841


containing 400 g/litre dimethoate HSR000188





Perfekthion S-1 HSR000965

Danadim HSR100129

Technical concentrate containing

950 g/litre maldison HSR000189


containing 500 g/litre maldison HSR000190

Malathion-treated wheat HSR100407


200 g/litre methomyl HSR000584

Armourcrop Insecticide HSR007761


240 g/litre oxamyl HSR000791

Water dispersible granule

containing 500 g/kg pirimicarb HSR000703


containing 500 g/kg pirimicarb HSR000704

Piritek HSR007884

Dovetail HSR008052

Smoke generator containing 225

g/kg pirimiphos-methyl HSR000186


containing 25 g/litre permethrin

and 475 g/litre pirimiphos-methyl

HSR000187

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June 2013




HSR000192

Attack HSR100602

Approved with controls for 15

years Approval code


containing 800 g/litre diazinon

(Substance A)

HSR000174


g/kg diazinon HSR000175

Granular material containing 50 -

54 g/kg diazinon HSR000176


g/kg of diazinon HSR000177


containing 200 g/litre diazinon HSR000178



and 25 g/litre permethrin

HSR000179

Emulsion (oil in water) containing

600 g/litre diazinon HSR007700


500 - 600 g/litre diazinon HSR000180



(Substance B)

HSR000181





(Substance C)

HSR000183



Diazamax 800 HSR002481


years Approval code


containing 400 g/litre fenamiphos HSR000198

Nemacur 400EC HSR000956

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June 2013

Fenafos 400 HSR002480

Nematak 400EC HSR007769

Nemacur CS HSR007894

Canyon HSR100282

Methamidophos (active

ingredient) HSR002863


600 g/litre methamidophos

(Substance B)

HSR000203



(Substance A)

HSR000226


containing 500 g/litre prothiofos HSR000200

Granular product containing 200

g/kg terbufos HSR000216


years Approval code


containing 1000 g/litre

fenitrothion

HSR000201

Phorate (active ingredient) HSR003058


g/kg phorate HSR000210

Declined

Benomyl (active ingredient)


g/kg benomyl

Carbofuran (active ingredient)

Carbosulfan (active ingredient)


g/kg carbosulfan

Dichlofenthion (active ingredient)

Ethion (active ingredient)

Famphur (active ingredient)

Isazofos (active ingredient)

Omethoate (active ingredient)

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June 2013

Phoxim (active ingredient)


containing 500 g/litre phoxim


containing 300 g/litre pyrazophos

Dustable powder containing 2

g/kg carbaryl, 20 g/kg maldison

and 5 g/kg rotenone

1.1. The reassessment application relates to organophosphate and carbamate (OPC) plant protection

insecticides approved under HSNO. In total, 88 approvals for OPC active ingredients and plant

protection insecticide formulations manufactured in New Zealand or imported are included in the

reassessment. The substances being considered are the following active ingredients and/or

insecticides containing these active ingredients:

Acephate

Benomyl

Carbaryl

Carbofuran

Carbosulfan

Chlorpyrifos

Chlorpyrifos-methyl

Diazinon

Dichlofenthion

Dichlorvos

Dimethoate

Ethion

Famphur

Fenamiphos

Fenitrothion

Isazofos

Maldison (malathion)

Methamidophos

Methomyl

Omethoate

Oxamyl

Phorate

Phoxim

Pirimicarb

Pirimiphos-methyl

Prothiofos

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June 2013

Pyrazophos

Terbufos

1.2. The following active ingredients and/or insecticides containing these active ingredients will no

longer be able to be manufactured or imported as the approvals to do so have been declined:

benomyl, carbofuran, carbosulfan, dichlofenthion, ethion, famphur, isazofos, omethoate, phoxim

and pyrazophos.

1.3. The following active ingredients and/or insecticides containing these actives have time limited

approvals and the substances will cease to be approved from the dates specified below.

diazinon (1 July 2028);

fenamiphos, methamidophos, prothiofos and terbufos (1 July 2023);

fenitrothion and phorate (1 July 2016).

1.4. All other substances continue to be approved but are subject to additional controls. These

additional controls will come into effect from 1 July 2015.

1.5. The Committee considers that as well as the default controls already in place on these approvals

based on their hazard classification, additional controls should be applied to all insecticides that

have been approved. These include:

Setting application parameters such as maximum application rates and

frequencies

Restricting the method of application such as prohibiting aerial application of

some substances and restricting indoor application to automated methods

A label statement to indicate that the substance is an OP or carbamate

Label warnings of risks to bees

Re-entry intervals

Requiring users of OPCs to hold approved handler certification.

1.6. Full details of the controls and the Committee’s evaluation are set out in this document. A

complete list of controls applied to each substance that has been approved is set out in a

separate Annex accompanying this decision.

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June 2013

2. Background

Organophosphates and carbamates

2.1. Organophosphates and carbamates (OPCs) are insecticides used against a broad range of

insect pests for a variety of purposes including plant protection, veterinary medicine, public

health (e.g. for pest control in hospitals, restaurants etc.) and industrial uses (e.g. for warehouse

or industrial structure pest control). They have been widely used internationally for many

decades.

2.2. Plant protection insecticides based on OPCs are considered to play a key role as part of

agricultural pest management programmes for the horticultural, grass/pastoral and ornamental

sectors in New Zealand. They are also used for biosecurity purposes to control and/or eliminate

insects, pests and pathogens from live plant material (e.g. nursery stock) entering New Zealand

or being cleared at the border.

2.3. Both organophosphates (OPs) and carbamates affect the nervous system by inhibiting the

enzyme acetylcholinesterase. Acetylcholinesterase breaks down acetylcholine, a substance

which transmits signals between nerves, or between nerves and various organs and tissues in

the body. By inhibiting acetylcholinesterase, OPCs cause accumulation of acetylcholine, leading

to overstimulation of the nervous system. Enzyme inhibition caused by carbamates is more

rapidly reversible than the inhibition caused by OPs.

2.4. The acute health effects resulting from exposure to high levels of OPCs are well known from

animal studies and numerous human poisoning incidents. Short term exposure can result in

symptoms including increased sweating and salivation, dizziness, fatigue, runny nose or eyes,

nausea, intestinal discomfort, confusion and changes in heart rate. At high levels of exposure

more severe effects such as paralysis, seizures, loss of consciousness and death may occur.

2.5. As well as acute toxicity, concerns have been raised over the potential for OPCs – in particular

OPs – to cause longer term adverse health effects in humans. These include the potential for

chronic health effects following acute poisoning and for effects as a result of chronic exposure to

low levels that do not cause the clinical signs or symptoms of poisoning. Research on these

aspects is ongoing.

2.6. OPCs are also harmful to the environment. They are very toxic to the aquatic environment and to

terrestrial invertebrates (e.g. bees), and in general they are also toxic to birds.

Organophosphates and carbamates in New Zealand

2.7. In New Zealand, many OPCs were transferred from former chemical management regimes to

management under the HSNO Act in 2004. Since that time, a number of OPCs were included on

the EPA’s Chief Executive Initiated Reassessment (CEIR) List. This list comprises hazardous

substances for which information that the EPA is aware of suggests there may be a need to

review their approvals.

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June 2013

2.8. In the last five years, the EPA has reassessed three OPs on the CEIR list. As a result, the

approval for methyl-parathion was revoked; the approval for a plant protection substance

containing trichlorfon was phased out and all approvals for azinphos-methyl and formulations

containing it have been, or are currently being, phased out.

Previous group reassessment approach

2.9. Applications for the reassessment of a further four organophosphates – acephate, diazinon,

dichlorvos and methamidophos – were notified in 2010 and 2011. Based on information received

in submissions on these applications, EPA staff determined it would be more efficient and

effective to reassess a larger group of OP insecticides at one time.

2.10. This broader assessment was approved by the Chief Executive, who also considered that

carbamates approved as plant protection insecticides, veterinary medicines, public health and

industrial treatments should be reassessed at the same time as the organophosphates. This is

because of their similar mode of action and because, according to product labels, carbamates

and OPs are often used to manage the same pests on the same crops with similar, if not

identical, withholding periods.

2.11. The rationale for the group reassessment approach was:

Dealing with substances which have similar effects in a single group

reassessment will ensure that any risks that may arise from the substitution of

one OPC substance for another are properly understood and managed;

Substance-by-substance reassessments of OPC insecticides may lead to a

gradual decrease in the available products. Reassessing these substances as a

group will result in greater certainty for industry and government agencies about

the tools available to them in future. Certainty about future availability should

help to direct research and development in alternative long-term solutions for

pest control;

An integrated approach will ensure consistent and effective controls to manage

risks are put in place across the group of substances;

The approach is a more efficient use of industry and EPA resources by reducing

the number of reassessments being undertaken; and

Reassessing the group of OPC insecticides will allow the EPA to meet the

needs of industry and ensure that there are tools for responding to biosecurity

events while protecting the health and safety of people and the environment.

2.12. Following the decision to conduct a group reassessment, the applications for acephate,

diazinon, dichlorvos and methamidophos were withdrawn so that they could be included in this

group application for reassessment.

2.13. Submissions that were made on the applications for acephate, diazinon, dichlorvos and

methamidophos have been made available to the Committee to inform our considerations. The

information was also made publicly available on the EPA website.

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Plant protection uses

2.14. Due to the large scale of the group reassessment, the EPA decided to restrict the

reassessment to substances used as plant protection insecticides separately from those used as

veterinary medicines or for other purposes (e.g. public health and industrial uses). Therefore, this

decision relates to OPC active ingredients and/or formulations containing these active

ingredients that are used as plant protection insecticides.

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3. The Reassessment of OPC plant protection insecticides

Grounds

3.1 As noted above, in 2008 and 2009 the Environmental Risk Management Authority (ERMA)

established grounds to reassess substances containing the organophosphates acephate,

diazinon, dichlorvos and methamidophos. Grounds were established on the basis of new

information available about the effects of these substances. The application reference numbers

for these substances are: diazinon (ERMA200398), dichlorvos (HRC08004), acephate and

methamidophos (ERMA200399 - combined application).

3.2 The information that the grounds for reassessment of acephate, diazinon, dichlorvos and

methamidophos were based on was accessed from overseas regulators including the United

States Environmental Protection Agency (US EPA), Australian Pesticides and Veterinary

Medicines Authority (APVMA), the European Union’s Standing Committee on the Food Chain and

Animal Health, and the Canadian Pest Management Regulatory Agency (PMRA). The information

had led to changes to registrations and to some of these substances not being available in

overseas jurisdictions. It is clear that some uses overseas of acephate, diazinon, dichlorvos and

methamidophos had been retained for socio-economic reasons rather than because the risks to

human health or the environment could be adequately controlled.

3.3 On 31 August 2012, the Chief Executive of the EPA submitted an application to establish whether

there were grounds for reassessment of 32 OPCs and/or formulations containing these active

ingredients. In addition, the application included two further formulations of diazinon which had

not been included in the earlier grounds application for diazinon (ERMA200398).

3.4 On 16 October 2012, a decision-making Committee of the EPA considered the grounds

application in accordance with section 62(2) of the Act, and decided that there were grounds for

reassessment. The decision was made on the basis that there was significant new information

available on these OPCs which had led overseas regulators to restrict the use of many OPC

insecticides based on the effects of these substances on the environment and human health.

3.5 Of the 36 OPCs for which grounds have been established2, 28 are used in plant protection

insecticides. It is these 28 OPCs that are the subject of this decision. In total, 88 approvals

(active ingredients and insecticide formulations) are included in the reassessment.

The application

3.6 An application for the reassessment of OPC active ingredients and/or plant protection insecticides

containing these OPCs was prepared by EPA staff on behalf of the Chief Executive under section

63 of the Act.

2 This number includes the 32 OPCs for which grounds were established in 2012, plus acephate, diazinon, dichlorvos and methamidophos.

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3.7 EPA staff sought information from a wide range of sources on the way that the substances are

used in New Zealand. Initial risk assessments were performed based on use patterns extracted

from the Novachem manual3 and product labels. These risk assessments and the use patterns

evaluated were then consulted on through two rounds of stakeholder engagement and data

gathering before the application was prepared.

3.8 During these rounds of stakeholder engagement and data gathering, feedback was also sought

on the practicality, economic viability and sustainability of proposed additional controls, and on the

benefits associated with use of the substances for specific crop sectors.

3.9 EPA staff obtained publicly available toxicological and ecotoxicological data specific to the

substances under review from international regulatory bodies.

3.10 The EPA also obtained the following peer reviews of specific aspects of the evaluation from

external experts:

The risk assessments performed for the original applications for diazinon,

acephate and methamidophos were peer reviewed by two Australian

toxicologists (Brian Priestly, Monash University and Peter Di Marco, Golder

Associates);

Data used for the risk modelling were reviewed by Martin Edwards (Toxicology

Consulting Ltd);

Benefits information, evaluation and recommendations were reviewed by staff at

Sapere Research Group and Plant & Food Research. In addition there was a

meeting to review the benefits evaluation attended by staff from Sapere

Research Group, and Plant & Food Research, as well as David Steven of IPM

Research Limited and Dave Lunn, a technical expert from the Ministry of

Primary Industries;

Proposed controls were reviewed by David Manktelow (Manktelow and

Associates Ltd), a consultant to the horticulture industry.

3.11 The Chief Executive submitted the application for reassessment on 1 November 2012.

Legislative basis for the application

3.12 The application for the reassessment of OPC plant protection insecticides was lodged pursuant

to section 63 of the Act and, as required under that section, deemed to be an application made

under section 29 of the Act. Section 29 requires the decision-making Committee to consider

positive and adverse effects of the substance and to make a decision based on whether or not the

positive effects of the substance outweigh the adverse effects of the substance.

3.13 Consideration of the application followed the relevant sections of the Act and the decision-

making Methodology established under section 9 of the Act.

3 http://www.novachem.co.nz/

http://oscar/General.aspx

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Appointment of Committee

3.14. The following members of the HSNO Committee were appointed in accordance with the Crown

Entities Act 2004 to consider the application in accordance with a delegation under section

19(2)(b): Ms Helen Atkins, Dr Val Orchard, Associate Professor Deborah Read, Mr Damian

Stone and Dr Kevin Thompson.

Timeline

3.15. The timeline for the application was as follows:

Action Date

Application formally received 1 November 2012

Application publicly notified 2 November 2012

Public submissions closed 22 January 2013

Evaluation and Review Report circulated 18 February 2013

Hearings held 4 and 7 March 2013

Waivers

3.16. Under section 59(5), the Committee waived the following statutory time limits:

Section 59(1)(c) allow 30 working days from the date of public notification for the

receipt of submissions;

Section 58(2) any information received by the Committee should be made

available to all submitters at least 10 working days before the hearing.

3.17. Before waiving these time periods the Committee satisfied itself that:

The applicant and the persons making submissions consent to that waiver; or

Any of those parties who have not so consented will not be unduly prejudiced.

Ministerial call-in

3.18. The Minister for the Environment was advised of the application on 2 November 2012 in

accordance with section 53(4)(a) of the Act and given the opportunity to ‘call-in’ the application

under section 68. The Minister did not call in the application.

Notification of the application

3.19. In accordance with section 53 of the Act, the application was publicly notified on the EPA

website on 2 November 2012 and advertised in the Christchurch Press, Dominion Post, New

Zealand Herald, Otago Daily Times, Waikato Times, Northland Advocate, Marlborough Express

and Manawatu Evening Standard on 3 November 2012.

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3.20. An application summary was also sent to government agencies which were identified as having

a specific interest in the application and interested parties who had previously indicated that they

wished to be notified of this application.

Māori interests and concerns

3.21. Sections 6(d) and 8 of the Act require that decision-making under the Act takes into account the

relationship of Māori and their culture and traditions with their ancestral lands, water and other

taonga4 as well as the principles of the Treaty of Waitangi (Tiriti ō Waitangi).

3.22. Accordingly, the EPA conducted national consultation with Māori prior to lodging the formal

application to canvass Māori opinion and information about issues or concerns posed by the

continued use of the OPC substances under review. The EPA held hui in Blenheim, Rotorua and

Whangarei in order to facilitate this. In addition, a presentation on the reassessment was made at

the EPA’s 2012 Māori Environmental Management Hui, which had significant Māori attendance

from across the country.

Evaluation and Review (E&R) report

3.23. EPA staff prepared an E&R report to provide the decision-making Committee and submitters

with a review of the submissions received in response to the public notification of the

reassessment application.

3.24. In preparing this report, EPA staff reviewed all the submissions and prepared responses to

significant issues raised.

3.25. The E&R report was circulated on 18 February 2013.

Further information

3.26. Prior to the hearing, further information was obtained and made available via the EPA website:

A review of certain epidemiological evidence relating to potential health effects

of long term exposure to low levels of OPCs prepared by Dr Petra Muellner

(Epi-Interactive)

A report from Ngā Kaihautū Tikanga Taiao

A late submission by DuPont relating to the risk assessments for methomyl and

oxamyl.

Information available for the consideration

3.27. The decision-making Committee had available for its consideration the application and the

consultation report, the E&R report, the epidemiology review paper, the Ngā Kaihautū Tikanga

Taiao report and the written submissions.

4 A taonga is anything considered valuable or precious to Māori and can be tangible or intangible.

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June 2013

3.28. The Committee also requested that EPA staff present the risks and benefits associated with

each of the OPC use scenarios under review in a different format. Further information on the

risks and benefits associated with OPC use in the home garden, including on the overseas

regulatory status for home garden use of these substances was also requested by the

Committee.

3.29. Subsequent to the hearings held in Wellington and Auckland, the Committee received further

information under section 58(1) of the Act from submitters as follows:

A technical review by EPA staff of the late submission by DuPont relating to the

risk assessments for methomyl and oxamyl. This was made publicly available

via the EPA website on 12 April 2013 and submitters were allowed 10 working

days to comment. Two responses were received, from DuPont and Market

Access Solutionz;

A response from Pesticide Action Network Aotearoa New Zealand (PANANZ)

on the submissions of Dow AgroSciences and Bill Brett for the home garden

sector;

A response from Bill Brett to the comments from PANANZ plus additional

information on the retail value of OPCs sold in home garden packs and the

availability of alternatives;

Responses from Market Access Solutionz, the Animal Remedy and Plant

Protectant Association and the Ministry for Primary Industries (MPI) to a

question from the Committee on how recent changes to approvals of

fenamiphos in Australia could affect supply in New Zealand;

Additional information from MPI regarding prospects for alternatives to

fenamiphos for nematode control;

Further information from Gourmet Paprika and Gourmet Blueberries;

Further information from the Bay of Plenty Regional Council on a suspected OP

poisoning incident that was mentioned during the hearing.

3.30. This information was made available on the EPA website and submitters were informed as new

information became available.

3.31. EPA staff also prepared a written ‘right of reply’ response to significant points raised in the

hearing, which was made publicly available via the EPA website on 19 April 2013.

3.32. The Committee also requested and received feedback from Market Access Solutionz, Rural

Contractors, Dow AgroSciences, DuPont and David Manktelow on revisions made to the R-4

control (relating to management of spray drift) following the hearing, and from Market Access

Solutionz on proposed additional controls for terbufos.

Public consultation, the hearing and site visit

3.33. In total 36 public submissions were received on the OPC application, with 22 submitters

indicating that they wished to be heard in support of their submissions at a public hearing. Some

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submissions, such as that from Market Access Solutionz, were from organisations that

represented the views of many individuals or agricultural industry sectors.

3.34. In accordance with section 60 of the Act and clause 2(b) of the HSNO Methodology, the

hearing was held on the following dates at the following locations:

Date Location

4 March 2013 Environment Court, Wellington

7 March 2013 Holiday Inn Auckland Airport, Auckland

3.35. In addition, the Committee went on a site visit on 8 March 2013 to a lemon orchard, a

greenhouse and a potato processing facility, where we were shown examples of the effects of

pests on untreated potatoes and carrots. The purpose of the site visits was to see the practical

operations and samples of crops that had been affected by pests usually managed by OPCs, to

provide context for the Committee.

3.36. The hearing was formally closed on 16 May 2013 once all the additional requested information

and the EPA right of reply noted above had been provided.

Hearing

3.37. The Committee wishes to acknowledge and thank all the submitters for investing significant

resources in making their submissions to us. These submissions have greatly assisted us in

understanding the issues that arise in relation to the various recommendations we have to

consider. In this section of the report the Committee refers specifically to those who presented in

person. In doing so, this in no way detracts from those submissions that we received in writing.

The Committee wishes to assure all submitters that all of the submissions received have been

fully considered as part of this decision.

3.38. The Committee heard from a number of organisations and individuals in relation to the home

garden use of OPCs as follows:

John Liddle, Nursery and Garden Industry Association of New Zealand; and

Bill Brett, Brett & Associates on behalf of himself, 13 independent garden

centres and for individual home gardeners.

3.39. Large retailers such as Mitre 10, the Warehouse and Bunnings were not submitters to the

reassessment.

3.40. The key concern for these home gardeners, and representatives of home gardeners, is that the

risks to home gardeners and bystanders have been overstated in the E&R report and therefore

the constraints and controls recommended for home garden use were not commensurate to the

risks.

3.41. Mr Brett accepted that the level of expertise in the garden centres was not what it was 10 to 15

years ago. Mr Brett considered that packaging and labelling could be substantially improved.

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For example, the current practice of not using the word “poison” on substances that were clearly

toxic and ecotoxic, Mr Brett felt, only misled those members of the public using these

substances.

3.42. Instead of the controls proposed in the E&R report, Mr Brett considered that there should be a

requirement for garden retailers to have a GROWSAFE™ (Growsafe) certified person who could

provide point of sale specialist advice. Growsafe is the brand of the New Zealand Agrichemical

Education Trust. Growsafe training covers the knowledge and practices required for safe,

responsible and effective use of agrichemicals and is based on the best practice requirements

set out in the New Zealand standard for management of agrichemicals NZS8409:2004.

3.43. Mr Brett noted that the most commonly used OP in the home garden setting was diazinon for

grass grub and porina caterpillar control. It was Mr Brett’s submission that diazinon was the one

substance for the control of these lawn pests for which there were no alternatives for home

gardeners and that a way needed to be found to ensure this substance is still available for home

garden use.

3.44. Rural Contractors NZ Ltd presented and told the Committee that their members apply OPCs in

public (and private) places commercially. They told us that their members undertake proper

training and refresher courses and that they have a national certification programme in place that

achieves this. Members generally undergo blood cholinesterase monitoring every 12 months

following the Ministry of Business, Innovation and Employment (formerly Department of Labour)

guidelines.

3.45. The Committee was told that the key concern for the Rural Contractors was not to have

duplicate or, worse, conflicting controls. They considered that the training that is undertaken by

their members, the requirements in the various regional air plans (under the Resource

Management Act (RMA)), and the best practices embodied and regulated via NZS8409:2004

(such as reducing spray drift via droplet size, nozzle size and using shelter belts) are all sufficient

to manage the risks associated with OPC application.

3.46. An issue in relation to the ventilation control proposed by the staff in the E&R report was also

questioned by the submitter who claimed the standard cab ventilation system provides adequate

protection to a driver without respiratory protection.

3.47. The Committee heard from the New Zealand Agrichemical Education Trust who also advocated

for the NZS8409:2004 Code of Practice and Growsafe. The Trust commented that the controls

imposed on substances are the basic requirements and that the key is good practice which is

embodied in the Code and applied in practice via the Growsafe training courses. The Trust

raised concerns over too much reliance on the approved handler regime and told the Committee

that it considered the regime does not guarantee good practice. Comparisons between

Growsafe and the approved handler regime were made with Growsafe being the preferred

requirement due to the hours of training required, the level of oversight provided and the fact that

Growsafe training is sector tailored.

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3.48. Beef and Lamb NZ and Deer Industry New Zealand presented together. Their written

submissions were very detailed and provided clear comments on the decision these

organisations wished the Committee to make on a substance by substance basis. The

Committee heard how important the sectors that these industry organisations represent were to

the domestic and export markets in New Zealand. The general concern raised by the industries

was that the approach to reassessment in the application documentation and in the E&R report

overstated the risks and understated the benefits, leading to risk averse recommendations.

3.49. Ministry of Primary Industries (MPI). MPI have two distinct roles in relation to the application,

namely:

As a regulator in relation to food residues

As a user of OPCs in relation to biosecurity, both pest incursion response and

plant importation health standards.

3.50. In relation to the latter, a key concern of MPI is the continued availability of fenamiphos for use

against pest nematodes, particularly of root and pasture crops. The Committee heard that

limiting the use of OPCs to biosecurity purposes only would likely mean the products would

become unavailable in New Zealand as they will not be kept here for biosecurity reasons alone.

3.51. In relation to food residues, the Committee heard MPI’s position on the interrelationship

between the setting of Acceptable Daily Intakes (ADIs) under HSNO and the setting of Maximum

Residue Limits (MRLs) under the Food Act 1981. This is an issue of particular concern to the

horticulture sector which addressed the Committee at the Auckland hearing, as noted below in

this decision.

3.52. The Committee heard from Waikato Tainui River Trust and Te Rūnanga o Ngāi Tahu. Both

submitters generally supported the recommendations in the E&R report but had some concerns

about the information used to support the risk assessments undertaken. The concerns are that

the risk assessments were based on very limited pathways. For example there is no information

known about the effects of OPCs on waterways and on native species especially those important

as a food source or those that are considered taonga species.

3.53. The Sustainability Council of New Zealand raised concerns about the manner in which the EPA

has undertaken the risk assessment process for this group of OPCs. In general the Council was

of the view that insufficient regard had been paid to the need for caution as is required by the

HSNO regime resulting in too much regard being paid to the benefits and not enough to the risks.

The Council was concerned that group reassessments do not adequately address risks on a

substance by substance basis.

3.54. The primary concern of Federated Farmers of New Zealand was in relation to the phase out

periods recommended, especially for those substances where there was no alternative and no

likelihood of there being an alternative in the medium term future. They were also concerned

with the level of prescription recommended in some of the controls noting that in a biological

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June 2013

system flexibility and rapid response is often needed to combat emerging problems. Federated

Farmers noted a concern around the consequences for MRLs caused by altering ADIs.

3.55. At the hearing the Committee heard from Nufarm NZ Ltd, Dow AgroSciences and DuPont (who

was accepted as a late submitter). Some of the submissions were substance specific such as

Dow’s concerns around chlorpyrifos and DuPont’s issues with methomyl and oxamyl. In terms of

any changes to controls that would affect labelling, industry reminded the Committee that time to

make changes is needed. Like the industry groups and organisations, these submitters were

concerned to ensure that controls were sensible and reasonable and did not duplicate or

contradict current good practice such as that embodied in NZS8409:2004.

3.56. Gourmet Blueberries Limited and Gourmet Paprika provided the Committee with more detailed

information on the nature of their businesses. We heard that chemicals are always the last resort

in any pest management system. For paprika, the chemicals used are primarily methamidophos

and dichlorvos but the continued availability of chlorpyrifos was vital. For blueberries,

chlorpyrifos is used in a very limited way but it is critical to deal with grass grubs that attack and

destroy blueberry roots.

3.57. The Auckland Council spoke in support of its submission and reiterated its concerns with the

approved handler regime. The primary concern of the Council is that reliance on the approved

handler control alone is not sufficient to manage the risks. In a related remark, the Council noted

that all its relevant staff had done Growsafe training which ranges from a basic one day course to

a very professional three day application course. Generally the courses were rated as being very

good. The Council also reiterated its submission on the need for urgent research into the toxic

effects of other spray tank chemicals including surfactants. Finally, the Council noted that care is

needed in applying a one-size-fits-all control (for example setting buffer zones). Any controls

need to consider the nature of the chemicals and the mode of application to manage risk.

3.58. The Bay of Plenty Regional Council commented on the confusion that still exists around

responsibility for HSNO enforcement. The Regional Council enforces HSNO, primarily through its

regional plan controls, but has limited funding to do so. In general the Council was advocating

for more stringent controls and shorter phase out for many of the chemicals on the reassessment

list.

3.59. Meriel Watts from the Pesticide Action Network Aotearoa New Zealand (PANANZ) spoke to

their submission and reiterated the concerns around the chronic human health effects of the use

of OPCs. She raised a criticism about the limited nature of the studies reviewed in the

Epidemiological Literature review and the Committee was urged to acknowledge these

limitations. PANANZ’s particular concern is in relation to home garden use and the Committee

was invited to immediately prohibit home garden OPC use. PANANZ accepts that, for

commercial growers, there are no alternatives to some of the chemicals and therefore it is

accepted that some limited ongoing use of these should continue for a defined period.

Generally, PANANZ wanted to see the approvals for all OPCs on the reassessment list revoked

in shorter periods than the E&R report recommended. PANANZ also addressed its specific

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submission on chlorpyrifos and posed the question of what the EPA will need to do if that

substance is listed on the Stockholm Convention list of persistent organic pollutants (POPs).

3.60. The Animal Remedy and Plant Protectant Association (ARPPA) told the Committee about their

concern that the E&R report recommended phase outs in the absence of any viable alternatives

to some of the chemicals used for pest incursion. ARPPA also reiterated the concern that the

horticultural industry has made around the relationship of ADIs and MRLs. The Committee were

reminded by ARPPA that the use of chemicals on many minor crops in New Zealand does not

represent a national benefit but that does not mean these minor crops are unimportant. ARPPA

also reminded the Committee that maintaining chemicals for biosecurity purposes alone is not

practical due to market size in relation to registration costs.

3.61. Richard Donald from the Orchid Association (but representing himself) spoke and reminded the

Committee that OPCs are not only used on food crops. He noted that, for orchids, there is

always the option of fumigation with methyl bromide to kill pests. Mr Donald also reiterated

reservations about the approved handler regime and generally considered that the various

controls around chemical use would benefit from modernisation – for example around notification

to neighbours and the option to utilise modern communications technology.

3.62. The Foundation for Arable Research and Horticulture New Zealand presented an extremely

thorough and detailed case in support of their submissions.

3.63. The Committee heard from Nikki Johnson of Market Access Solutionz and the sector groups

listed below individually. The Committee specifically wishes to thank the following people and

their organisations for attending in what the Committee appreciated was a busy time of the

growing season for many of them:

Arable – Mike Parker

Persimmons – Geoff Peach

Avocado – Henry Pak and John Cotterell

Citrus – Rick Curtis

Strawberries – Peter McIntyre

Tamarillos – Robin Nitschke

Process Vegetables & Fresh Vegetables – Stuart Davis

Potatoes – Stephen Ogden

Onions – Mick Ahern

Greenhouse crops – Lex Dillon and Jason Colbert

Kumara – Andre de Bruin.

3.64. From these growers and representatives of growers we heard very specific concerns relating to

the E&R recommendations for various chemicals. Without detracting from the individual issues

which the Committee has carefully considered, the common themes expressed by Ms Johnson

were:

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a. The importance generally of diazinon for broad-scale use and the concerns about

the implications of the ADI values set by the Committee on the MRLs that MPI will

set (see last point below);

b. The fact that many of the uses the Committee was being told about were off-label

and for ‘minor’ (i.e. not national benefit in monetary terms) crops;

c. That it is important that controls under HSNO do not duplicate, or worse, contradict

controls already in place under the RMA in regional plans;

d. Embodiment of NZS8409:2004 and Growsafe within the HSNO controls context is

necessary to ensure good practice;

e. Controls need to provide for individual flexibility (e.g. standard buffer zones are

impractical for many small scale (in terms of land area used) crops – a reiteration

of the concern the Auckland Council raised that a one-size-fits-all approach is not

appropriate;

f. Research into chemical alternatives is fraught due to cost and the size of the New

Zealand market and unique pest problems like grass grub in pasture. Having said

this, the Committee was told that, where funding is available, research is

underway and will continue to be done but it is simply not a quick fix to the issues

of OPC use. The Committee were told about the importance of Integrated Pest

Management (IPM) programmes and research on the use of beneficial insect

predators as biological control agents.

g. The relationship between the ADIs set by the EPA and the implications for the

MRLs set by MPI is of considerable concern to industry. MRLs are the key factor

that impacts on the industry’s access to international and domestic markets and

EPA changes to the ADIs could have flow on effects. The key concern that was

raised was over the manner in which New Zealand uses the Codex MRL standard,

a standard which applies to many imported crops but not domestic crops.

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4. Sequence of the consideration

4.1. In accordance with the Methodology, and as outlined in the Decision Path used by the

Committee (Appendix G), the approach to the consideration adopted by us was to:

Review the available information (clause 8);

Establish the hazard classifications for each substance and derive the default

controls that are prescribed under section 77 for each classification;

Identify potentially significant risks, costs and benefits (covered by clauses 9

and 11);

Assess the potentially significant risks and costs (risks were assessed in

accordance with clause 12, and costs in accordance with clause 13) using

recognised techniques (clause 24). The adequacy of the default controls

prescribed under section 77 was considered alongside the assessment of risks

and costs to determine whether those controls should be varied and identify

where additional controls need to be applied, under section 77A, to mitigate any

acceptable risks;

Consider all the risks and costs and determine whether the individual risks and

costs (when combined) are negligible or non-negligible;

Review any non-negligible residual risks and determine whether the decision

should follow clause 26 or clause 27;

Establish the approach to risk with respect to the individual non-negligible risks

in accordance with clause 33;

Consider (a) whether any of the non-negligible risks could be reduced by

varying the controls in accordance with sections 77 or 77A, and (b) the cost-

effectiveness of the application of controls in accordance with clause 35 and

sections 77 and 77A;

Assess the benefits associated with this application in accordance with clauses

9, 11, 13 and 14 and section 6(e);

Taking into account the risk characteristics established under clause 33, weigh

up the risks, costs and benefits in accordance with clause 26 or clause 27 and

clause 34 and section 29 taking into account aspects of uncertainty (clauses 29,

30 and 32) and determine whether the application should be approved or

declined;

Confirm and set the controls.

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5. Treaty of Waitangi (Tirito ō Waitangi)

Introduction

5.1 Under section 8 of the Hazardous Substances and New Organisms Act (1996), all persons

exercising powers and functions under the Act are to take into account the principles of the Treaty

of Waitangi (Tiriti ō Waitangi).

5.2 In reference to the “principles” of the Treaty of Waitangi, the Committee has focused its attention

on the generally accepted principles of partnership, participation and protection.

5.3 The principles of partnership and participation refer to the shared obligation on both the Crown

and Māori to act reasonably, honourably and in good faith towards each other to ensure the

making of informed decisions on matters affecting the interests of Māori. Additionally, the

Waitangi Tribunal has previously recommended that “Environmental matters, especially as they

may affect Māori access to traditional food resources also require consultation with Māori people

concerned.”5

5.4 The Crown’s duty of active protection is the obligation to take positive steps to ensure Māori

interests are protected. Further, that this protection is not merely passive but extends to active

protection of Māori people in the use of their lands and waters to the fullest extent practicable.

Response from submitters

5.5 The Committee heard from Waikato Tainui River Trust and Te Rūnanga o Ngāi Tahu who both

acknowledged that OPCs are important tools for biosecurity/pest management and generally

supported the recommendations in the E&R report.

5.6 Both submitters had some concerns about the limited information used to support the risk

assessments. For example, they recommended a greater emphasis should be placed on impacts

on the environment as a whole, and that particular attention be paid to the impact on mahinga kai

and native species. Also, that there are a significant number of data gaps especially in regards to

the impact to native/taonga species. In their opinion the risk assessments completed by the staff

were not adequate as they ignored the impacts of important exposure pathways such as runoff

and did not consider chronic risks.

5.7 Te Rūnanga o Ngāi Tahu suggested that the EPA make better use of the annual national

environmental management hui so that the likely impacts for Māori, of these types of

reassessments, are fully understood. Further that education is provided to Māori communities

around the impact of OPCs especially around the gathering of kai from areas adjoining spraying

operations.

5 P. McDonald (September 1991) “Consultation with Iwi” Planning Quarterly pp8-10

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5.8 Te Rūnanga o Ngāi Tahu also made specific reference to using signage to indicate where OPC

substances have been used so that persons gathering food from locations near OPC treated

areas are aware that OPCs have been used nearby.

Ngā Kaihutū Tikanga Taio

5.9 Ngā Kaihutū Tikanga Taio (NKTT), the statutory committee established under the Act to advise

the EPA on Māori issues, prepared its own report on the reassessment application during the

public submissions period. The Committee also heard an oral presentation (via teleconference)

from NKTT where there was an opportunity for them to expand on their submission and answer

questions.

5.10 NKTT generally supports the decision to reassess this group of insecticides and the EPA staff

recommendation to revoke or phase-out 19 of the 29 OPCs assessed6. Additionally, NKTT

supported the extended phase out period for diazinon to enable time for suitable alternatives to be

identified.

5.11 NKTT agreed that there were data gaps but considered that it was unlikely that further

evaluation of native species’ susceptibility would alter the risk profile of OPCs. However, NKTT

considered that undertaking research on the impacts to New Zealand specific situations in the

future is warranted.

5.12 Finally, NKTT recommended that non-compliance issues be appropriately addressed by

enforcement agencies.

6 The EPA staff consultation report focused on 29 OPCs but information received in submissions indicated that one substance (bendiocarb) is also used for non-protection purposes. Bendiocarb was subsequently withdrawn from the reassessment so the number of OPCs being reassessed is 28.

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6. The substances

6.1. The reassessment application relates to existing approvals for 28 active ingredients and/or

formulations containing these active ingredients. More specifically, it includes:

Eleven active ingredients and/or formulations containing these active

ingredients that are not approved for use in New Zealand, or are approved for

containment and export only. These substances either have HSNO approvals

as active ingredients only, or are not included in products registered under the

Agricultural Compounds and Veterinary Medicines (ACVM) Act as plant

protection products in New Zealand (Benomyl, Carbofuran, Carbosulfan,

Chlorpyrifos-methyl, Dichlofenthion, Ethion, Famphur, Isazofos, Omethoate,

Phoxim, Pyrazophos).

Nine active ingredients and/or formulations containing them for which all

approvals relate to plant protection (Acephate, Dimethoate, Fenamiphos,

Methamidophos, Oxamyl, Phorate, Pirimicarb, Prothiofos and Terbufos).

Plant protection insecticides containing eight active ingredients that are also

included in formulations used for non-plant protection purposes (e.g. veterinary

medicine, public health or industrial purposes). This reassessment only

addresses the formulations containing these actives that are used only for plant

protection purposes. It is intended that the implementation of changes for these

active ingredients and other formulations will be completed in a subsequent

reassessment. The active ingredients themselves are not part of the present

reassessment, and will be considered when the other uses of these active

ingredients are assessed (Carbaryl, Chlorpyrifos, Diazinon, Dichlorvos,

Fenitrothion, Maldison (Malathion), Methomyl and Pirimiphos-methyl).

6.2. In total, 88 approvals are included in the reassessment.

6.3. The full list of these 88 approvals is set out in Appendix A.

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7. Hazard classifications

7.1. As part of the reassessment, EPA staff have reviewed the HSNO classifications for the OPCs

and formulated substances containing these active ingredients. A number of changes to the

classifications were proposed.

7.2. Classifications for the active ingredients were reviewed based on data from international

regulators and other authorities. For the formulated substances containing the active ingredients,

classifications took into account:

The revised classifications for the active ingredients

Changes in the mixture rules applied by the EPA in establishing classifications

(summation, rather than additivity, is now used for mixture rules to derive

ecotoxicity classifications for mixtures)

Any changes in the classification of the other components of the mixtures that

may have occurred since the original classification was carried out.

7.3. The Committee has adopted the classifications listed in table 2 of Appendix B.

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8. Acceptable Daily Intakes

Role of the EPA in establishing Acceptable Daily Intake values

8.1. The Acceptable Daily Intake (ADI) is a value used to assess the human health significance of

estimated intakes of pesticides from food. The ADI is derived from toxicological and/or

epidemiological findings and is set to represent the oral intake of a pesticide that a human can

consume day after day for a lifetime without adverse effects. ADIs are important because MPI’s

Agricultural Compounds and Veterinary Medicines (ACVM) Group use them to assess dietary

pesticide intakes and to establish Maximum Residue Levels (MRLs) for pesticides on food crops.

8.2. The EPA has the legislative mandate under the Hazardous Substances (Classes 6, 8, and 9

Controls) Regulations 2001 to set exposure standards for hazardous substances. This includes

setting values for the ACVM Group to use in assessing the human health significance of food

residues for pesticide and veterinary medicine active ingredients.

8.3. The EPA’s role under the Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations

2001is to define the following values:

Acceptable Daily Exposure (ADE) values – a daily exposure to a substance that

is not considered to represent a health hazard over a lifetime of exposure

Potential Daily Exposure (PDE) values – established to represent various

sources of exposure. The EPA has generally set three PDE values:

o PDEfood, usually 70% of the ADE

o PDEdrinking water, usually 20% of the ADE

o PDEother, usually 10% of the ADE.

8.4. After setting the values, the EPA advises the ACVM Group of the ADE and PDEs, with particular

attention to the PDEfood as this value is used by ACVM as the ADI.

8.5. The role of the EPA in setting ADE and PDE values under HSNO applies to applications for

hazardous substances containing new active ingredients and to existing substances that are

under reassessment.

Selection of ADIs under the present reassessment

8.6. The EPA staff and the ACVM Group have had an ongoing dialogue about the fact that some of

the ADI values set by the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) were outdated

prior to the EPA’s previous reassessment applications for dichlorvos, diazinon, acephate and

methamidophos. Recognising that the EPA’s role is to set exposure limits (ADE and PDEs), the

ACVM Group indicated that it would value advice from the EPA on suitable values for use in

dietary risk assessment, pending revision by the JMPR. ADE and PDE values had not been set

for the existing substances when they were transferred to the HSNO Act in 2004, and the

reassessment process was seen to provide the opportunity to set them.

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8.7. As a result of the reassessment applications for acephate, diazinon, dichlorvos, and

methamidophos, concern was raised by MPI relating to the use of 70% of the ADE for derivation

of the PDEfood, as this effectively results in a New Zealand ADI lower than overseas values. It

was agreed to allow 100% of the ADE for the PDEfood in the case of the OPCs, so that the value

used would be in line with overseas values.

8.8. While the EPA consultation report listed the proposed ADIs, as these values are being proposed

under the HSNO Regulations, it would have been more correct to have listed these values as the

ADE or PDEfood. Whether these values are called ADIs or ADEs/PDEfood is not a significant

issue as the actual numbers are numerically the same, since it has been agreed that the

PDEfood is 100% of the ADE, i.e. ADI = PDEfood = ADE.

Rationale for the selection of ADI values

8.9. The ADIs selected and recommended to be used by the EPA staff are the same as those used in

Australia by the Australian Pesticides and Veterinary Medicines Authority (APVMA), with the

exception of acephate, diazinon, methamidophos and pirimicarb. The ADIs are discussed under

the following three categories:

Acephate, diazinon, dichlorvos and methamidophos

OPCs for which APVMA values were selected (carbaryl, chlorpyrifos,

dimethoate, fenamiphos, fenitrothion, maldison, methomyl, oxamyl, phorate,

pirimiphos-methyl, prothiofos, terbufos)

Pirimicarb, for which a value set by the European Food Safety Authority (EFSA)

was selected.

Acephate, diazinon, dichlorvos and methamidophos

8.10. The ADIs for these four active ingredients were initially determined from full toxicology data

reviews undertaken as part of the original reassessment applications. Submissions were

received raising concerns about the proposed ADIs (with the exception of dichlorvos) and the

uncertainty factors used to address data gaps in the derivation of the values.

8.11. As a result of the submissions the ADI values for acephate, diazinon and methamidophos were

externally peer reviewed by two Australian toxicology experts. The reviews led to modification of

the uncertainty factors to address the need for additional precaution due to the data gaps. This

resulted in the original ADIs being adjusted to those currently recommended, which, EPA staff

have advised, are consistent with values established by overseas regulators.

OPCs allocated APVMA values

8.12. In relation to the OPCs which the staff have recommended are allocated the APVMA values, a

complete review of the toxicological and epidemiological information for these active ingredients

was not undertaken by EPA staff prior to the selection of the ADIs. This is because the EPA

adopted the position, with general support from industry, that it would carry out a comprehensive

group reassessment. In choosing to carry out the group reassessment it became evident that it

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would be an inefficient use of resources to duplicate work done overseas on ADIs. Therefore, all

of the values recommended by the staff are those that have been set by international regulators

based on a scientific evaluation.

8.13. As set out in the EPA staff consultation report, a list of the ADIs established by other regulatory

agencies was prepared and staff then selected a value for each active ingredient.

8.14. The EPA staff selection gave preference to APVMA ADIs for the following reasons:

It provides a consistent set of values from one regulator for as many of the

values as possible;

APVMA is also undertaking a review programme which includes several of

these OPCs;

There are harmonisation advantages in aligning assessments between Australia

(APVMA) and New Zealand (EPA and ACVM Group), including in relation to the

inputs (ADIs) used for the calculation of food MRL values; and

New Zealand and Australian regulatory agencies involved in registration of plant

protection products have a close working relationship and a number of

registrants have products which are registered in both jurisdictions.

Pirimicarb

8.15. The APVMA value for Pirimicarb was not considered appropriate due to it having been set over

25 years ago (1987) and the fact that it was anomalously low in comparison to more recent

values set by other regulators. Therefore, the value selected was the European Food Safety

Authority (EFSA) value set in 2006.

Implications of ADIs under the ACVM Act

8.16. The Committee is acutely aware that the ADIs listed have a flow on effect to the regulatory

requirements of the ACVM Group of MPI, as the two pieces of legislation they operate under are

linked in this way.

8.17. The ACVM Group sets MRLs for agricultural compounds under the Food Act. In doing so, the

ACVM Group assesses the potential human health risks from dietary exposure to residues in

food for each compound by comparing the estimated dietary intake to the ADI.

8.18. MPI’s submission indicated that there are expected to be dietary intake concerns for three of

the OPC active ingredients under review: diazinon, fenamiphos and methamidophos. The ACVM

Group will therefore need to consider whether any further reduction of the dietary exposure

assessment is necessary. This could be achieved by removing label claims to limit use or

reducing residue levels (either by reduced number of applications and/or application rates or

longer withholding periods).

8.19. The horticultural industry also raised a number of concerns about the implications of the ADIs

including:

The potential removal of uses currently on the label;

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The potential for restriction of off-label use;

The potential need to undertake residue trials to support lower MRLs (in some

cases the MRLs currently used for the dietary intake assessment of OPCs are

considered to be significant overestimates of crop residues); and

International standards issues relating to New Zealand accepting MRLs set by

the Codex Alimentarius Commission for imported food, which may be higher

than domestic MRLs which apply to food grown in New Zealand. Codex is part

of an international food standards programme run by the World Health

Organisation (WHO) and the Food and Agriculture Organisation (FAO) and

seeks to protect the health of consumers and ensure fair trade practices.

8.20. The Committee acknowledges the submitters’ concerns relating to the dietary intake

assessment. For this reason, the Committee sought further information from MPI and the EPA

staff on the interrelationship of the two regimes. The Committee also expressly requested the

staff to include this matter in its right of reply. The difficulty for the Committee is that the

assessment of MRLs is beyond the scope of what the Committee can consider under the HSNO

Act.

8.21. The Committee notes that the ACVM Group is engaging with the agricultural industry and

registrants about the process for refining or deleting label claims. We endorse this approach and

recommend that this dialogue continues to ensure that any resultant MRL, label claims and

possible restrictions on off label use does not lead to a perverse outcome that potentially

undermines this decision.

8.22. The Committee has adopted the ADI/PDEfood values proposed by EPA staff as set out in

Appendix C.

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9. Current management regime

9.1. The current controls applying to OPC plant protection insecticides were prescribed as part of the

approval for these substances under the Act. Other requirements that must be complied with are

set out in the ACVM Act, Resource Management Act (RMA), the Health and Safety in

Employment Act 1992, Biosecurity Act 1993 and the Civil Aviation Act 1990.

9.2. The current controls under HSNO comprise the default controls assigned to the substances

based on their hazardous properties, with variations and additions to these controls which were

applied to the substances either at the time of transfer from control under the Pesticides Act 1979

to the framework of the Act, or when an approval was granted following the time of transfer under

Part 5 of the Act.

9.3. The current controls were used as a reference point in the evaluation and the risk assessment

on the use of OPC plant protection insecticides. This assessment was carried out with the

assumption that the current controls, together with some additional controls as specified in the

consultation report, are in place.

9.4. The primary users of OPC insecticides in New Zealand are the horticulture, pasture/turf and

ornamentals and flower industries. OPCs are used in these industries to control a broad range of

pests. Home gardeners also use OPCs to control pests on fruit and vegetables, flowers,

ornamentals and lawns.

9.5. Many commercial growers follow formal good practice standards which intend to ensure the safe

and efficient use of agrichemicals including OPCs. The main standards followed are those of

Good Agriculture Practice (GAP) and New Zealand Standard NZS8409:2004.

9.6. GLOBALGAP is an internationally recognised food safety tool for describing best practice for

safe and effective chemical use (among other things). There is a local version of GLOBALGAP

called New Zealand GAP. For the markets where retailers accept systems equivalent to

GLOBALGAP additional features are incorporated into the New Zealand GAP used domestically,

and this practice has been recognised as equivalent to GLOBALGAP. Under GAP generally the

user should achieve the desired control without excessive use of chemicals, leaving a residue

which is the smallest amount practicable. GAP may achieve some risk reduction in relation to

food residues, but is unlikely to reduce the human health and environmental risks identified in the

application.

9.7. NZS8409:2004 is the New Zealand Standard for the Management of Agrichemicals. It provides

practical and specific guidance on the safe, responsible and effective management of

agrichemicals, including plant protection products. NZS8409:2004 is an approved code of

practice under HSNO. As a code of practice it has mandatory and non-mandatory elements

embodied within it. Adherence to the mandatory requirements means that HSNO obligations for

the entire life cycle of an agrichemical are met. Adopting the non-mandatory best practice

measures will also ensure that HSNO obligations are met.

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9.8. In addition many users of agrichemicals are Growsafe trained and hold appropriate certificates. A

Growsafe certificate is issued at the completion of a Growsafe course, and demonstrates that

agrichemical users understand their obligations and best practice for the use of agrichemical

products (within the scope of their certification).

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10. Key sectors for use of OPC plant protection insecticides

Introduction

10.1. The Committee has primarily focused its assessment of the benefits and adverse effects of

OPC plant protection insecticides on three key areas of use: pasture, horticulture and the home

garden. An additional important consideration was the use of OPCs for biosecurity purposes.

Pasture

10.2. The Committee recognises that from a national economic perspective pastoral farming is the

most significant sector in which OPC plant protection insecticides are used. The pastoral sector

supports the dairy, beef, sheep and deer industries and its value was estimated at around $24

billion in information provided by the Dairy industry7. Also related to this sector is the fodder and

forage sector. Fodder and forage crops are not sold, but support the same stock-related

industries as pasture does, and are considered the second largest crop grown in New Zealand

after pasture.

10.3. OPCs are used by the pasture sector to control a variety of pests including clover root weevil,

black beetle, black field cricket, porina and grass grub species. Grass grub is of particular

concern as it can cause millions of dollars’ worth of damage every year. Diazinon and, to a lesser

extent, chlorpyrifos are considered to be the only effective and reliable options for control of

grass grub in pasture.

10.4. The Committee acknowledges that alternative control options are not currently available for

most of the OPCs used in pasture. In particular, grass grub is a New Zealand-specific pest

problem and therefore global crop protection companies are not investing in new insecticides to

control this pest. The Committee was informed at the hearing that while research is ongoing in

New Zealand further work is needed to identify suitable control options and then test their

effectiveness in the field. Such testing takes considerable research resources and time and is

hard to justify or undertake in a market as small as New Zealand’s.

10.5. In relation to the adverse effects of OPC use in the pasture sector these have been identified

by the EPA staff as those effects relating to human health risks for operators, re-entry workers

and bystanders, and risks for aquatic organisms, birds and bees. The Committee accepts that

these are the primary adverse effects of concern and further consideration of these is dealt with

below.

Horticulture

10.6. The Committee considers that the horticulture and arable sectors are significant value to New

Zealand. While some individual product groups are relatively small industries in isolation, the

7 www.pasturerenewal.org.nz/UserFiles/File/BERL%20Pasture%20Renewal%202011%20Analysis.pdf

http://www.pasturerenewal.org.nz/UserFiles/File/BERL%20Pasture%20Renewal%202011%20Analysis.pdf

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Committee recognises that in combination the sectors have a value of $2.7 billion. In addition,

many of the individual groups have clear regional benefits in terms of providing employment and

contributing to the diversity of the New Zealand horticulture industry and domestic food supply.

An associated sector is the grape industry, which is worth over $1 billion in annual sales.

10.7. Some serious pests, like the citrus flower moth, grow inside the developing flower bud and are

not controlled by surface contact with insecticides. Control of this pest can only be achieved

using a systemic insecticide (such as acephate) of which there are very few available

10.8. In terms of assessing the benefits, the Committee has considered the sector as a whole.

Having said this, the Committee is cognisant of the regional benefits of particular crops such as

the importance of the kumara industry to the Northland region and the citrus industry in Northland

and Gisborne. In relation to these specific industries the Committee has taken the benefits of

these into account.

10.9. The Committee acknowledged that many of the OPCs under review are considered critical by

the horticultural and arable sector. Some substances are only considered critical for a small

number of crops, whereas others such as diazinon, chlorpyrifos and pirimicarb are considered

critical for a wide range of crops.

10.10. As with the arable sector, alternatives are not currently available for many of the OPCs used by

the horticulture and arable industries. The industry also reminded the Committee that it is

necessary to have these OPCs available in their toolbox of pest control to deal with incursions

such as happened recently with the Tomato/Potato Psyllid (TPP) and to assist in managing the

development of pest resistance to individual OPCs.

10.11. As with the pastoral sector the adverse effects of OPCs in the horticulture and arable sectors

primarily relate to human health risks for operators, re-entry workers and bystanders, and risks

for aquatic organisms, birds and bees.

Home garden

10.12. Several OPCs are used by gardeners at home to control pests on fruit and vegetables, flowers

and lawns.

10.13. The Committee was informed that alternative insecticides are available for all the OPCs used in

the home garden except for diazinon which is used to control grass grub in lawns. The

alternatives are considered to be relatively widely used although many do not yet have label

claims for all the crops for which OPCs have label claims.

10.14. The Committee recognises that gardening is an important and popular pastime and occupation

in New Zealand which offers a range of benefits including exercise, a feeling of well-being and

satisfaction and the ability to grow fresh produce for consumption.

10.15. However, the Committee also has concerns about the potential human health risks from use of

OPCs in the home garden, in particular risks for children and pregnant women. Almost all home

garden uses of OPCs that were modelled in the EPA staff risk assessment have risks for re-entry

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and bystanders and in a home garden setting these risks are difficult to mitigate by preventing

entry. Although operator risks were assessed as negligible, the risk assessment is based on

operators wearing appropriate personal protective equipment (PPE) and handling the

substances appropriately. The Committee is concerned that an untrained home gardener would

not have adequate knowledge and awareness to manage the risks from using and storing these

high hazard products.

Biosecurity

10.16. Another important area where OPCs are used is for the maintenance of New Zealand’s

biosecurity.

10.17. MPI uses OPCs in order to meet its responsibilities for excluding, eradicating and effectively

managing pests under the Biosecurity Act 1993. This includes use in the event of a biosecurity

incursion, in surveillance systems (e.g. lures or traps) and in the treatment of live plant material

imported into New Zealand.

10.18. The Committee was informed that if an arthropod pest (such as TPP) enters the country,

chemicals may be required to eradicate the pest, or control its spread while response decisions

are being made. In these cases broad-spectrum compounds, such as OPCs, may be the only

immediate way to achieve eradication or control. It is therefore considered critical that chemicals

such as OPCs are available for these emergency situations. The Committee notes that

biosecurity incursions can be extremely expensive, both in terms of the cost of response and

eradication actions, and the potential loss in export trade of horticultural produce. Such

incursions can also have a significant detrimental and long-lasting effect on the ability to supply

certain markets where there is a perception that an incursion here could cause adverse effects in

an overseas market or result in an incursion there.

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11. Assessment of benefits

Summary

11.1. The Committee’s view, set out in more detail below, is that, with the exception of the home

garden use of OPCs, the benefits of many of the OPCs considered in this reassessment

application are significant both at a national and regional level.

Introduction

11.2. The Committee reviewed the EPA staff assessment of the potential benefits associated with

OPC plant protection insecticides, as set out in the Consultation Report and E&R Report.

11.3. In addition, the Committee heard from a number of submitters, particularly those from the

arable and horticulture sectors as to the benefits that OPCs have in managing pests.

Market economy benefits

11.4. The Committee heard that the most significant benefit from the use of OPCs relates to their use

to support the export and domestic agricultural industry and the associated positive effects on the

market economy.

11.5. The submissions identified a number of key benefits provided by many of the substances under

reassessment.

11.6. We heard that some of the generic benefits of OPCs can be delivered to varying degrees by

other substances. However, the overwhelming information we received is that it is the overall

combination of benefits that OPCs provide that farmers and growers value. For some pests, the

Committee heard that there are few or no alternative substances that can adequately replace

OPCs. The generic benefits of OPCs include:

Efficacy: The reliability and effectiveness of OPCs were identified as the most

important benefits.

Broad spectrum: OPCs control a wide variety of pests and this means that

fewer applications of OPC insecticides can be used to achieve the same level of

control as more targeted substances, because one OPC will control a variety of

pests that would require multiple applications of other products.

Cheaper: OPCs are generally cheaper than other products.

Short pre-harvest intervals: Many OPCs only require a short period between

application and harvest which means crops can be harvested for human and

animal consumption soon after treatment which is particularly beneficial for

controlling some insect pests.

Short withholding periods: Workers and livestock can quickly return to a

sprayed area, maximising productivity of both the workers and the land.

Maximum Residue Limits: Meeting MRLs is important to ensure that

international trading partners do not reject the produce. For some crops, specific

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MRLs are set for OPCs. Use of other substances without MRLs may not be

permitted on crops exported to some overseas markets, or may require growers

to meet default MRLs which can be difficult.

Resistance Management: a number of different chemicals are needed in

rotation to control a pest, otherwise it may become resistant. OPCs are

considered an important tool for resistance management.

Biosecurity: OPCs are considered an important tool for biosecurity, which is

crucial for New Zealand producers:

- to stop pest incursions at the New Zealand border

- to eliminate pest threats that breach the New Zealand border

- to meet the phytosanitary requirements of our international trading partners

to eliminate pest threats that have not been detected and managed at the

New Zealand border.

11.7. The information provided by submitters was that these combined generic benefits allow good

quality crops to be produced in sufficient quantities to meet demand and ensure New Zealand

growers remain a major contributor to local and national economies.

11.8. In addition to the generic benefits, many specific OPC active ingredients are considered to be

particularly effective in controlling specific pests. This makes them beneficial on a number of

crops where these pests are difficult to control.

11.9. EPA staff evaluated the level of benefit provided by use of specific OPCs for each of the crops

on which feedback indicated they are used on. The main focus of the evaluation was the level of

benefit provided to the New Zealand economy. The EPA staff evaluation was primarily based on

the level of use of the substance, the level of economic benefit provided by the specific crop and

the availability of alternative pest control options. Details of the EPA staff assessment are in the

Consultation Report and E&R report.

11.10. Rather than focusing on the benefits for individual crops, the Committee has focused its

assessment on the three main areas of use: pasture, horticulture and the home garden. We now

refer to each of these in more detail.

Benefits from use in pasture

11.11. As stated in section 10, pasture is the largest crop grown in New Zealand, supporting the dairy,

beef, lamb and deer industries. A related sector is fodder and forage, which also supports the

stock industries. Several OPCs are used in these sectors and therefore the benefits were

assessed across the range of OPCs by EPA staff as ranging from low (for example maldison,

pirimicarb and pirimiphos-methyl) to high (chlorpyrifos and diazinon).

11.12. The Committee notes that diazinon and, to a lesser extent, chlorpyrifos are considered

particularly important to these sectors. This is because of their value in treating a broad spectrum

of pests, and in particular because of their effectiveness for the control of New Zealand grass

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grub, a pest specific to New Zealand. Grass grub can cause millions of dollars in damage to

crops and pasture.

11.13. To date, there has been little success in finding effective alternative control options for grass

grub. The Committee was informed that research is ongoing in New Zealand but further work is

needed to identify suitable options. If an effective alternative is identified, field trials would then

be required followed by work to register any alternative substance for use in New Zealand. The

Committee was informed that as a best case scenario this work would take at least six years

from the time of identifying a suitable alternative. At this point in time no suitable alternative has

been identified.

11.14. The Committee notes that information in submissions also indicated that dimethoate is critical

for use on forage brassicas. This information led the EPA staff to revise its benefits assessment

for the use of dimethoate on fodder and forage to ‘high’ and the Committee agrees with this

recommendation.

Benefits from use in horticulture

11.15. The Committee recognises the high contribution to the national economy provided by the

horticulture and arable sector as a whole. It also notes that some specific crops, although

comparatively small in isolation, provide substantial regional benefits.

11.16. As with the pastoral sector, diazinon and chlorpyrifos were again identified as being of critical

importance. These substances are used to manage a broad range of pests, including grass grub,

on a variety of crops. Diazinon was strongly supported by the following producers, arable, maize,

avocado, beans/peas, carrot, salad leaf, citrus, kumara, strawberry and the processed tomato

industry. The use of chlorpyrifos is supported by the arable, maize, avocado, cucurbit, kumara,

onion, persimmon, potato, processed vegetable, strawberry, summerfruit and sweetcorn

producers.

11.17. A number of other OPCs are also considered critical for various horticultural crops, including

acephate, carbaryl, maldison, methomyl, oxamyl, pirimicarb and pirimiphos-methyl.

11.18. Prothiofos is only used on grapes, where it is considered to be critical for the control of

mealybugs which are a vector for Grapevine Leaf Roll-associated Virus type 3 (GLRaV-3).

GLRaV-3 shortens the commercial lifespan of vineyards. Although there are some alternatives

available or under development, currently these have efficacy issues. Information provided

during consultation and stakeholder feedback indicates that loss of prothiofos could result in the

loss of viability of vineyards in the northern regions of New Zealand.

11.19. The Committee took particular note of information provided in submissions and at the hearing

on three substances for which EPA staff had proposed phase out periods of three or five years,

namely, fenamiphos, methamidophos and terbufos.

11.20. Fenamiphos is considered by many in the horticultural sector to be critical for the control of

nematodes pests of potatoes, carrots and parsnips. Fenamiphos is the only product registered in

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New Zealand for the control of nematodes on potatoes, and is the main product used for

nematode control on carrots and parsnips. The Committee was informed that although oxamyl is

also registered for nematode control on these crops, it is significantly more expensive and does

not provide the same level of control.

11.21. These industries expressed concerns that a five year phase out period would not be sufficient

time to develop alternatives. Although development work by international companies is currently

underway, the industry is not aware of alternatives that could undergo field trials in the next few

years. The Committee was also informed that nematodes are particularly difficult to research as

their presence in the soil can be sporadic and hard to identify before trial work starts. It is difficult

to determine if nematodes are present in sufficient numbers for a trial to be successful before the

work begins, and it is often not until the research is underway that this information is known.

11.22. The Committee also notes that the carrot industry provides significant benefits to regions such

as Ohakune, where approximately 25-30% of the total national carrot volume is grown.

11.23. Methamidophos is considered critical for a number of pests on a range of crops. The

Committee heard from a number of individuals at the hearing about the importance of this

substance for the control of the recent devastating TPP in potatoes, tomatoes, and tamarillos,

and for green vegetable bug on sweetcorn and maize. Not only does the psyllid cause crop

damage it also is a vector for a bacterium (Liberibacter) that causes additional economic losses.

11.24. Control of TPP or green vegetable bug is considered vital for the ongoing existence of these

industries, all of which provide benefits for regional economies and collectively are nationally

beneficial. For example, the Committee was informed that an inability to grow field tomatoes

would be strongly felt in the Hawkes Bay, where the crop is not only grown but also supports the

local workforce by providing product to the Heinz Wattie tomato processing factory.

11.25. Submitters indicated that the phase out period of five years recommended by EPA staff is

unlikely to be an adequate time period for all of the pests for which methamidophos is used. In

this regard, the Committee notes that research into an alternative to methamidophos for green

vegetable bug started in the mid-1990s, but a successful alternative has not yet been found.

11.26. Terbufos is considered essential for the successful production of kumara, where it is used for

symphilid, stem weevil and wireworm control. The Committee notes that kumara has special

cultural significance for New Zealand. Kumara has been grown in New Zealand for over 500

years and the taonga status of New Zealand kumara was acknowledged in the Waitangi Tribunal

findings into native flora and fauna8. The Committee also notes that, while kumara is a relatively

small crop on a national scale, its production has substantial benefits for the Northland region.

Over 90% of kumara are grown in Northland and it is the second largest agricultural industry in

the district after pastoral farming.

8 Waitangi Tribunal Report 2011. Ko Aotearoa tēnei: a report into claims concerning New Zealand law and policy affecting Māori culture and identity. Te taumata tuatahi. Wai 262.

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Benefits from use in the home garden

11.27. The Committee notes that the primary benefit from use of OPCs in the home garden relate to

the ability to produce fresh fruit and vegetables and the satisfaction that comes from successful

growth of produce, flowers and other ornamentals including lawns. The Committee was informed

that with the exception of diazinon granules for the treatment of grass grub and porina on lawns,

there are effective alternatives for all the OPCs used in the home garden. While these

alternatives do not have label claims for all the fruit and vegetables for which OPCs have label

claims, the Committee heard that these insecticides are used off-label. The retail value of

diazinon granules for the home garden was estimated at around $5 million, while the other home

garden use OPCs combined have a market value of just over $1 million. No quantitative value

has been able to be attributed to the use of OPCs in the home garden beyond the retail value.

Human health benefits

11.28. The Committee considers there are health benefits from OPCs resulting from employment in

farming and horticulture where OPC use is critical for pasture and some crops and from lower

food prices if crop yields are not reduced due to lack of pest control. The Committee also notes

the health benefits of home gardening from physical activity, fresh fruit and vegetable

consumption, and enhanced wellbeing from successfully growing lawns, flowers and crops.

Benefits to Māori

11.29. As noted in the Consultation report the concepts of kaitiakitanga9 and whaihua

10 as well as

ohanga (economic impact on the Māori economy) need to be taken into consideration in regards

to this reassessment.

11.30. The Committee heard from Iwi/Māori submitters who accepted and noted the positive role of

OPCs in supporting their role as kaitiaki in the protection of taonga koiora (native species) and

taonga tuku iho (other valued species such as kumara).

11.31. The Committee heard that a large number of Māori are employed in sectors that are affected by

this reassessment so to ensure whaihua (to pursue economic productivity) for whānau in certain

regions the continued use of certain OPCs is necessary for the financial stability of entire

whānau. In addition, given the growing nature of the Māori economy (ohanga) and asset base

following Treaty settlements, it is essential to position these assets in such a way as to enhance

their economic development. The Committee agreed with the EPA staff assessment that there

will be some benefits from OPCs on the relationship of iwi/Māori to the environment and in their

ongoing ability to develop economically.

Benefits to society and communities

9 Kaitiakitanga (guardianship) is the undertaking of responsibilities and obligations inherited from the atua (spiritual guardians) over the realms of those atua. These obligations and responsibilities are accrued through an intricate system of relationships with the environment, for the control and management of resources. 10 Whaihua in the context used by participants at the hui conducted as part of the consultation for this reassessment is defined as the pursuit of economic productivity.

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11.32. EPA staff identified a positive effect on society and communities in terms of reducing anxiety

associated with expectations of future capability to counter pest problems. Users of OPCs across

the industry sectors have expressed their concerns that loss of some or all of the OPCs would

have negative effects on themselves, their families and local communities.

11.33. The staff also noted that there may be a social benefit from the continued use of OPCs in that

they are generally cheaper to purchase than alternative substances.

11.34. As already noted OPCs are used by home gardeners who cite efficacy and cost as their main

benefits. Gardening is a popular pastime in New Zealand and it has been suggested that the

ability to successfully raise crops and flowers is considered an important contributing factor to the

health and well-being of participants and their families.

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12. Assessment of adverse effects

Summary

12.1. OPCs are known to be toxic to people and the environment. The mode of action by which they

kill pests (inhibition of the acetylcholinesterase enzyme) also affects humans and environmental

species including aquatic organisms, birds and beneficial insects including bees.

Introduction

12.2. The Committee reviewed the EPA staff assessment of the potential risks associated with the

use of OPC plant protection insecticides. The assessment primarily focused on risks to human

health and the environment.

Adverse effects on human health

12.3. OPCs are known to affect the nervous system through the inhibition of the enzyme

acetylcholinesterase. Acetylcholinesterase breaks down acetylcholine, a chemical which

transmits nerve signals. Inhibition of acetylcholinesterase results in accumulation of

acetylcholine, leading to overstimulation of the nervous system.

12.4. For organophosphates, even minor effects on enzyme levels are potentially of concern as it can

take several months for normal enzyme function to be restored. There is also a risk of cumulative

effects, as another exposure during a time of depressed cholinesterase enzyme levels can

further reduce these levels. This increases the probability than an individual may experience

adverse health effects. Enzyme inhibition by carbamates is more rapidly reversible. Repeat

exposures to organophosphate insecticides are therefore of greater concern to human health

than repeat exposure to carbamate insecticides.

12.5. A number of studies in laboratory animals and in human populations have shown an

association between prenatal and/or early postnatal organophosphate exposure and adverse

effects on the development of the nervous system for the fetus or in early childhood. In addition,

studies have indicated potential associations between exposure to some OPCs and

immunotoxicity, cancer, obesity and diabetes. This research has primarily focused on

organophosphates rather than carbamates. Feedback received in response to calls for

information on OPCs by the EPA cited reports of these health effects as issues of concern.

12.6. To date, international regulatory bodies have considered the critical effects of OPCs to be

neurotoxicity mediated by inhibition of the acetylcholinesterase enzyme, and their risk

assessments have been based on this endpoint. The Committee notes that the EPA staff have

taken the same approach and used health based guidance values set by international regulators

in this evaluation. The Committee is aware that some overseas regulators are investigating the

use of other endpoints in the risk assessment of organophosphates, but such work is still

ongoing.

Acute poisoning

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12.7. The acute effects of exposure to high levels of OPCs are well established from animal studies

and numerous human poisoning incidents.

12.8. Short term exposure can result in symptoms including increased sweating and salivation,

dizziness, fatigue, runny nose or eyes, nausea, intestinal discomfort, confusion and changes in

heart rate. At high levels of exposure more severe effects such as paralysis, seizures, loss of

consciousness and death may occur.

12.9. In addition to the immediate effects of OPC poisoning, there are a number of possible

neurological complications that can develop in the subsequent days-weeks following initial

recovery: Intermediate syndrome (IMS) and OP-Induced Delayed Polyneuropathy (OPIDP).

These effects appear to be associated with exposure to organophosphates rather than to

carbamates. IMS occurs in approximately 20% of patients around 2-4 days following high acute

exposure to organophosphates. IMS is associated with weakness of face, neck and respiratory

muscles and can result in respiratory failure. Exposure to very high levels of some

organophosphates can cause OPIDP, which generally occurs 1-4 weeks following single or

short-term exposures. OPIDP is relatively rare, and is characterised by cramping and weakness

of lower limb muscles (and in severe cases upper limb muscles as well) and difficulties with

muscle coordination.

12.10. The Committee notes that there is a paucity of data on OPC poisoning incidents in New

Zealand. Hospital admissions and Nation Poisons Centre calls data provide insufficient detail

about most cases, making it difficult to draw conclusions. The extent of acute poisoning relating

to plant protection use is unknown. The limited information that exists suggests that a large

proportion of accidental exposures occur at home and many of these appear to involve children.

12.11. The Committee was not convinced that the relative lack of reported cases is representative of

the level of acute poisoning in New Zealand. The symptoms of mild OPC poisoning are non-

specific and the time of onset varies depending on the route and severity of exposure and the

OPC. The Committee therefore considers under-recognition and under-reporting of acute OPC

poisoning is likely.

12.12. The former Department of Labour has produced guidelines for the monitoring of blood

acetylcholinesterase levels in workers exposed to OPs11

. The level of acetylcholinesterase in

blood acts as a marker for the level of the enzyme in nervous tissue. Following baseline test(s)

before OP exposure begins to establish a worker’s normal level, periodic testing detects whether

a regular OP user’s enzyme levels have decreased to such a level that further exposure could

result in symptoms. If the decrease from baseline level is 40% or greater workers should be

suspended from work until the level recovers.

12.13. There are no data available on the number of workers who are suspended from using OPs until

their enzyme levels recover or the extent of adoption of cholinesterase monitoring by regular OP

11 Occupational Health Service (2000). A Guideline to Promote Best Practice with Organophosphates. Wellington: Department of Labour.

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users. Whilst the Committee heard about some monitoring programmes it is concerned about the

variable knowledge and understanding among users of how to carry out monitoring effectively in

order to protect their health. Further work to enhance the effectiveness of biological monitoring is

needed.

12.14. As OPCs have been readily available for many decades the Committee considers it is likely

that many home gardeners do not fully appreciate the health risks not only to themselves but to

other household members, in particular children, from the use of OPCs.

Chronic health effects

12.15. As well as acute toxicity from OPC exposure, concerns have been raised over the potential for

longer term adverse health effects. This includes the potential for chronic health effects following

acute poisoning, and for effects as a result of chronic exposure to low levels that do not cause

the clinical signs or symptoms of poisoning.

12.16. Animal and human epidemiological studies have reported associations between acute and/or

chronic OPC exposure and a number of adverse effects. Examples of the type of effects that

have been raised as concerns are:

Neuropsychological effects e.g. on attention, perception and memory

Effects on motor function and muscle coordination

Effects on the development of the nervous system following pre-natal or

childhood exposure

Psychiatric illness e.g. anxiety and depression

Parkinson’s disease

Increased risk of cancer

Increased risk of obesity and diabetes.

12.17. In 1999, the UK Committee on Toxicity of Chemicals in Food, Consumer Products and the

Environment (COT) published a report which considered whether prolonged or repeated low

level exposure to organophosphates, or acute exposures to organophosphates at levels

insufficient to cause overt toxicity, can cause long-term adverse health effects.

12.18. This report focused on neurotoxic effects, and concluded that the balance of epidemiological

evidence supported the view that neuropsychological abnormalities can occur as a long-term

complication of acute organophosphate poisoning, particularly if the poisoning is severe. Effects

were most noticeable in neuropsychological tests involving sustained attention and mental agility.

12.19. With regard to neurological effects of low level chronic exposures to organophosphates, the UK

COT considered that the balance of evidence was less convincing, and made recommendations

for further research.

12.20. Since this time a number of further studies have been reported. In September 2012, the UK

COT considered a systematic review of the epidemiological literature on the effects of acute and

chronic organophosphate exposures on the nervous system, focusing on neurological and

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neuropsychological effects. Due to the complexity of the data the COT has established a

Working Group to consider the review in detail. The report from this Working Group is expected

to be available in 2014.

12.21. The Committee notes that the epidemiological literature review commissioned by the EPA is

limited as not all published papers were considered due to time constraints. However it does

include a recent systematic review of 14 occupational studies involving more than 1600 workers

which shows neurobehavioural effects12

and three US children’s cohort studies which

independently show associations between prenatal OP exposures and neurodevelopmental

effects in early childhood131415

.

12.22. Given the increasing suggestive evidence of neurodevelopmental effects from exposure to low

levels of OPs insufficient to result in acute poisoning, the Committee is particularly concerned

about the potential for harm to children (including the fetus) from home garden use.

Adverse effects on the environment

12.23. OPCs are harmful to living organisms in the environment and not only to insects. They are very

toxic to aquatic life and to terrestrial invertebrates (e.g. bees), and in general are also toxic to

birds. Acute and chronic risks for fish, aquatic invertebrates and birds have been identified for

many of the OPCs under review.

12.24. Incidents of harmful effects on wildlife due to OPCs have been reported overseas and in New

Zealand. In the USA there have been incidents of bird, fish and/or bee kills associated with a

range of OPCs including chlorpyrifos, dichlorvos, diazinon, fenamiphos, phorate, terbufos and

carbaryl. The majority of bird deaths occurred after exposure to lawns or turf on recreational

grounds such as golf courses treated with OPCs.

12.25. In New Zealand, an incident of indigenous game bird deaths in the Westport region was

reported in April 2012. Diazinon had been sprayed aerially on neighbouring farmland, and a

pathology report confirmed that the bird deaths were a result of diazinon poisoning. This incident

was reported to the EPA by Fish and Game New Zealand, who also stated that they have

received numerous complaints over the past decade regarding the poisoning of waterfowl

following treatment for grass grub, a pest commonly controlled with organophosphates.

Risk Assessment

12.26. EPA staff undertook a human health and environmental risk assessment for the OPCs currently

in use in New Zealand.

12 Mackenzie Ross S et al. (2012) Neurobehavioural problems following low-level exposure to organophosphate pesticides: a systematic and meta-analytic review. Crit Rev Toxicol 43: 21-44. 13 Mount Sinai Children’s Environmental Health Study: Berkowitz et al. 2004; Engel et al. 2007, 2011. 14 Columbia Center for Children’s Environmental Health: Lovasi et al. 2011; Rauh et al. 2006, 2011, 2012; Whyatt et al. 2004. 15 Center for the Health Assessment of Mothers and Children of Salinas Study: Bouchard et al. 2011; Eskenazi et al. 2007; Marks et al. 2010; Quirós-Alcalá et al. 2011; Young et al. 2005.

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12.27. The risks of adverse effects on human health were assessed by comparing predicted or

measured exposures of the substances to operators, workers re-entering a recently sprayed area

and bystanders to the maximum levels of exposure that are generally not expected to result in

harmful effects. The risks of adverse effects on the environment were assessed by comparing

predicted or measured exposures of the substances to wildlife against concentrations known to

cause a particular level of effect.

12.28. The data relating to the toxicological and ecotoxicological effects are based on animal or

human studies. Where possible, the toxicity and ecotoxicity data specific to the substances

evaluated are those used by other international regulators. In some instances key information

relevant to the risk assessment, such as higher tier operator or re-entry worker exposure

monitoring studies or dermal absorption data, were not available. In these instances EPA staff

followed international practice and used reasonable worst case scenarios or default values, or

did not calculate the risks.

12.29. Exposure was assessed based on information on application rates and methods provided by

stakeholder feedback, as well as the application rates and methods listed on product labels.

12.30. The risk assessment assumed that the default controls triggered by the hazard classifications

of the substances were in place, as well as the following additional controls: buffer zones, use of

PPE including respiratory protective equipment (RPE), label warnings of the effects on bees and

re-entry intervals (REI) specific to each OPC. As bees are expected to be killed when directly

exposed to the insecticides, it was considered that with a control to prevent application of OPCs

when bees are present all risks to bees would be negligible.

12.31. To allow a comparison between the benefits and the risks associated with the application of

OPCs, qualitative descriptors were developed to assign the level of risk into broad categories of

negligible, low, medium or high. As with the benefits assessment and in line with the EPA’s

Methodology, these qualitative descriptors took into account the likelihood and magnitude of an

adverse effect. The Committee is aware that even low risks are of concern.

12.32. Full details on the risk assessment approach and results can be found in the EPA staff

consultation report and accompanying summary and analysis documents for each sector.

Risks from use in pasture

12.33. A summary of the level of risk identified by EPA staff for each OPC used in pasture and fodder

and forage is presented in Table 1. A more detailed breakdown of the risks and benefits of each

OPC in each sector is included in Appendix D.

Table 1. Summary of the human health and environmental risk assessment for uses of OPCs in pasture

and fodder and forage

Active

ingredient

Operator

risk

Re-entry

worker risk

Bystander

risk Aquatic risk Bird risk

Chlorpyrifos N N N N, L N, L, M

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Active

ingredient

Operator

risk

Re-entry

worker risk

Bystander


Diazinon N, L, M N, L, M N, L N, L, M M, H

Dimethoate N N N N M

Fenamiphos H M M M H

Fenitrothion N, L N, L N, L N, L L, M

Maldison N N, L N N N, M

Phorate L N N N H

Pirimicarb N L N N L

Pirimiphos-

methyl N N N L, M L, M

Terbufos L N N N M

N = use scenarios with negligible risks were identified for this OPC; L = use scenarios with low risks were identified for this OPC; M = use scenarios with medium risks were identified for this OPC; H = use scenarios with high risks were identified for this OPC. It is important to note that even low risk represents a level of risk greater than the level of concern.

12.34. Based on the EPA staff risk assessment, the Committee notes that use of all of the OPCs used

in the pasture and/or fodder and forage sectors is associated with a risk of adverse effects for

human health and/or the environment, with the exception of maldison on pasture. The

substances with most human and environmental risks are diazinon (used in both sectors) and

fenamiphos (used for fodder and forage).

Risks from use in horticulture

12.35. A summary of the level of risk identified by EPA staff for each OPC used in the horticulture and

arable sectors (which also includes biosecurity uses and use on cymbidiums (orchids) and turf) is

presented in Table 2. A more detailed breakdown of the risks and benefits of each OPC in each

sector is included in Appendix D.

Table 2. Summary of the human health and environmental risk assessment for uses of OPCs in the

horticulture and arable sectors

Active

ingredient

Operator

risk

Re-entry

worker risk

Bystander


Acephate N, L, M N, L, M N, L N N, L, M

Carbaryl N, L N, L N, L N, L, M N, L

Chlorpyrifos N N N, L N, L, M N, L, M, H

Diazinon N, L, M, H N, L, M N, L, M N, L, M N, M, H

Dichlorvos N N N N N

Dimethoate N N N, L N N, L, M

Fenamiphos L, M, H N, M N, L, M N, L, M N, M, H

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Active

ingredient

Operator

risk

Re-entry

worker risk

Bystander


Fenitrothion N L L N, L M

Maldison N N, L N, L N, L, M N, L

Methamidophos N, L, M L, M N, L, M N, M M

Methomyl N, L N, L N, L N, L N, L, M

Oxamyl N, L N, L, M N, L N N, M, H

Phorate N, L, M N N N H

Pirimicarb N N, L N N, L N, L, M

Pirimiphos-

methyl N, L N, L N, L N, L, M N, L, M

Prothiofos M, H M L, M N, M L

Terbufos L, M N N N M


12.36. Based on the EPA staff risk assessment, the Committee notes that use of all of the OPCs used

in the horticulture and arable sectors is associated with a risk of adverse effects for human health

and/or the environment. The substances with most human and environmental risks are diazinon

and fenamiphos, methamidophos and prothiofos.

Risks from use in the home garden

12.37. A summary of the EPA staff risk assessment for OPCs used in the home garden is presented in

Table 3.

Table 3 Summary of the human health and environmental risk assessment for uses of OPCs in the home

garden

Active

ingredient Operator risk

Re-entry

worker risk

Bystander

risk Bird risk

Acephate N N L N

Carbaryl

(powder) N L L H

Chlorpyrifos

(handheld

granule

application)

N Not calculated L Not calculated

Chlorpyrifos

(knapsack

granule

application)

N N N L

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Diazinon (liquid)

L (gloves only

during mixing

and loading)

N (full PPE)

M M H

Diazinon

(granule) M Not calculated M H

Maldison

(powder) N L L H

Pirimiphos-

methyl N N L M


12.38. The Committee notes that all uses of OPCs in the home garden are associated with some risks

to human health and/or the environment. All but one use (knapsack granule application of

chlorpyrifos) is associated with risks to bystanders. The use of diazinon is associated with the

greatest risks for operators and bystanders.

12.39. The home garden is a place where exposure of the most sensitive individuals (i.e. pregnant

women and children) is likely to occur. Furthermore the risk assessment is based on the

assumption of operators wearing appropriate PPE and handling the substances appropriately,

and re-entry intervals being adhered to. It is considered unlikely that home gardeners will be

following these measures fully, and therefore the actual risks may be higher than those indicated

in the risk assessment.

12.40. The Committee is concerned that many home gardeners do not fully appreciate the health risks

not only to themselves but to other household members, in particular children.

12.41. Given the increasing suggestive evidence of neurodevelopmental effects from exposure to low

levels of OPs insufficient to result in acute poisoning, the Committee is particularly concerned

about the potential for harm to children (including the fetus) from home garden use.

Adverse effects on the relationship of Māori to the environment

12.42. Submitters expressed concern about the unknown and/or unmeasured effects of the

substances and their impact on the environment and human health. For example, there is little or

no research on how these chemicals affect puha and watercress harvested for food and other

aquatic species that may come into contact with OPCs via runoff from paddocks.

12.43. The Committee acknowledges that gaps in research in the New Zealand specific context exist

but consider that enough is known about the risks of OPCs to make an informed decision. It is

recommended (see below) that further New Zealand specific research is commissioned.

Adverse effects on society and communities

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12.44. In addition to human health effects or discrete incidents of harm to the environment there is a

broader adverse effect associated with the use of OPCs. This is the general social concern and

anxiety associated with the effects of these products. For example, OPCs have been known to

kill birds that feed on crops and grass that have been treated to control pests. The presence of

groups of dead birds is not only an incident of environmental harm (which can be modelled in the

risk assessment); it raises social concerns about the impact of these substances on ecosystems

and communities. Although recent bird deaths in New Zealand have been linked to the use of

diazinon, the social effects of this cannot be quantified.

12.45. The Committee is aware of community concerns about the health risks related to OPC use. In

general it is bystanders who are worried about unintentional exposure of themselves, their

children and pets to these substances. This is supported by regional council records of

complaints made to them about spray drift from agrichemical application. The risk to bystanders

has been modelled in the EPA staff assessment. However, there is an additional consideration

about the fear or anxiety that being exposed to OPCs can cause to individuals and communities

irrespective of whether exposure or any adverse health/environmental effect has occurred.

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13. International obligations

13.1. To achieve the purpose of HSNO, the EPA must consider the impacts of the application on

New Zealand’s international obligations.

13.2. The EPA staff have identified that OPCs must meet the World Health Organization/Food and

Agriculture Organisation Joint Meeting on Pesticide Specifications (JMPS) standards.

Codex

13.3. New Zealand is an active participant in the Codex Alimentarius Commission. The international

standards set by Codex for pesticides to protect the health of consumers and ensure fair trade

practices include ADI values and MRLs.

13.4. New Zealand sets its own domestic MRLs, but also recognises Codex MRLs for imported

foods. Food grown and sold in New Zealand must comply with the New Zealand Standards for

MRLs, while imported food must comply with either the New Zealand MRL Standards or Codex

MRLs.

13.5. An exception to this is food imported from Australia. Under the Trans-Tasman Mutual

Recognition Arrangement (TTMRA), food imported from Australia must comply with either the

New Zealand MRLs, Codex MRLs or Standard 1.4.2 of the Australia New Zealand Food

Standard Code.

Potential listing of chlorpyrifos under the Stockholm Convention

13.6. PANANZ noted that there is a potential for chlorpyrifos to be proposed for listing under the

Stockholm Convention as a Persistent Organic Pollutant (POP) and enquired as to what would

happen if chlorpyrifos were to be listed.

13.7. The Committee notes that chlorpyrifos has not yet been proposed to the Convention’s technical

body, the Persistent Organic Pollutants Review Committee (POPRC), for evaluation of POP

status. Currently it has been submitted to a preliminary screening assessment for POP

characteristics as part of work to assess alternatives to the Stockholm-listed pesticide

endosulfan. Of 110 potential alternative substances screened, chlorpyrifos was one of nine

chemicals which “may” meet criteria but this remained undetermined due to equivocal or

insufficient data. Prothiofos was another of these nine chemicals.

13.8. If chlorpyrifos or prothiofos were submitted to POPRC, it would then undergo a three stage

technical review process to determine whether it satisfies the requirements of the Convention.

These determinations take several years and any decision on the listing of these substances will

not take place until at least mid-2018.

13.9. The Committee acknowledges the potential for chlorpyrifos to be listed as a POP but until this

occurs the Committee must consider the current status of chlorpyrifos.

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14. Revised management regime

Introduction

14.1. Section 9 of this decision provides an overview of the current management regime for OPC

plant protection insecticides.

14.2. The Committee is aware that many users of OPCs follow standards which are intended to

ensure the safe and efficient use of agrichemicals including OPCs. These standards include

NZS8409:2004 and Growsafe certification. Nevertheless, the EPA risk assessment has indicated

that current use of OPCs under the regulatory management regime that applies has risks to

human health and the environment.

14.3. In order to reduce risks from OPCs, the Committee is proposing a number of additional

controls. These include:

Setting application parameters such as maximum application rates and

frequencies

Restricting the method of application such as prohibiting aerial application of

some substances and restricting indoor application to automated methods

A label statement to indicate that the substance is an OP or carbamate

Label warnings of risks to bees

Re-entry intervals

Requiring users of OPCs to hold approved handler certification.

14.4. In setting these controls the Committee has been mindful of the need to avoid unnecessary

duplication or contradiction of requirements of other codes of practice or regional council RMA

plans.

14.5. In addition, the Committee wishes to restrict and prevent the use of OPCs by untrained users in

the home garden. This is because of the Committee’s concerns about the potential for harm to

children (including the fetus) and that many home gardeners do not fully appreciate the health

risks not only to themselves but to other household members, in particular children.

14.6. The Committee considers that the most effective way to achieve this is to apply the approved

handler control to all OPC plant protection insecticides including those used in the home garden

situation. This will ensure that only individuals with a level of understanding of the risks

associated with insecticides, and how such substances should be handled, will be able to

purchase and use OPCs generally and in home gardens.

14.7. This would not preclude individuals obtaining the services of an approved handler – or

becoming an approved hander themselves – in order to apply diazinon granules, the only home

garden use OPC for which no alternatives are available. The Committee has decided that an

information sheet should be provided with diazinon granule products in order to communicate the

potential risks to household members and make clear that individuals should not re-enter treated

areas until granules are no longer present on the surface of treated areas.

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14.8. The Committee considers that there is currently a fine balance between the benefits and the

adverse effects for several of the substances in the reassessment application: diazinon,

fenamiphos, methamidophos, prothiofos and terbufos. The Committee anticipates that there is

the potential for the specific benefits currently possessed by these substances to decline with the

development of alternatives. When this occurs the risks of these substances are likely to

outweigh the benefits. The Committee has therefore decided to approve these substances for a

fixed period of time, either 10 years (fenamiphos, methamidophos, prothiofos and terbufos) or 15

years (diazinon).

14.9. For fenitrothion and phorate, the Committee has decided to approve plant protection

insecticides containing these substances for a period of three years in order to allow time for

them to be disposed of through use.

14.10. For substances not in use in New Zealand, the Committee considers that their approvals

should be revoked, with the ability to dispose of any existing stocks through use.

14.11. The Committee has established that the implementation of new additional controls should take

place two years from this decision, in order to allow sufficient time for compliance with the

revised controls to be arranged.

14.12. The Committee is also making a number of recommendations including:

More research by industry on safer alternatives to OPCs

Routine monitoring of worker acetylcholinesterase levels to manage their health

Improvements to the approved handler regime.

Description of additional controls for the mitigation of risks arising from

OPC plant protection insecticides

14.13. Table 4 describes the additional controls the Committee is assigning to OPC plant protection

insecticides and the intent of each control. Not every control is applied to every approval included

in the reassessment. Details of which additional controls have been assigned to each approval

are provided in Appendix E. The full list of controls (default and additional) applied to each

substance is provided in the accompanying Controls Annex.

14.14. The phase-in of new controls and time-limited approvals were previously listed as controls,

however they are not considered to be controls as such by the Committee.

14.15. Phase-in of new controls (previously listed as control R-1 in the EPA staff consultation report

and E&R report): Where new controls are imposed on a substance, the revised control package

comes into effect after a transition period in order to allow for compliance with the revised

controls to be arranged. In each substance approval, the controls imposed as a result of this

reassessment will be identified with an implementation date.

14.16. Time-limited approvals (previously listed as control R-2 in the EPA staff consultation report and

E&R report): For approvals of substances that are to be phased out, a period of time is

established to allow for use or disposal of the substance. At the end of the time-limited approval,

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an approval for the substance will no longer exist and the substance may no longer be imported

into or manufactured in New Zealand. Each set of controls for a substance that is approved in a

time-limited fashion should include the following statement, with the relevant date inserted

depending on the length of the approval period: No person may import or manufacture after the

expiry of [DATE].

Table 4. Description of additional controls for the mitigation of risks arising from the use of OPC plant

protection insecticides

Control

Code Intent of control Example wording

R-3 APPLICATION PARAMETERS

Where restrictions in the use of a substance

are required to manage exposure to human

health and/or the environment, restrictions are

imposed on application of a substance being

used as a plant protection insecticide

(including maximum application rates,

frequencies or intervals as relevant).

Amendment July 2015:

This control was subject to amendment to

provide clarity regarding application of control

R-3 when used in situations when the term

“crop cycle” is not relevant (e.g. use on turf).

In such circumstances, the application

frequency applies per year.

CONTROL

(1) The person in charge of the application of a

substance and any person applying the

substance must ensure that application of

the substance is carried out in accordance

with the following application restrictions:

The substance may be applied at a

maximum rate of [quantity][active ingredient

substance] / ha, with a maximum application

frequency of [# times] per [time interval].

LABEL STATEMENT

(2) A person must not supply a hazardous

substance to any other person unless the

substance label shows the following

information:

(a) the maximum application rate;

(b) the maximum application frequency if

one is set.

(3) A person who is in charge of a hazardous

substance must ensure that the substance

label shows the information required by (2).

R-4 SPRAY DRIFT MANAGEMENT

In order to protect bystanders and/or sensitive

areas from exposure arising from off-target

deposition of the substance, application of the

substance is permitted provided that

measures are implemented by the applicator

to ensure that off-target deposition (i.e. spray

drift) is sufficiently minimised to ensure that

adverse effects beyond the property boundary

do not occur. The control is intended to

provide applicators with the flexibility to adopt

whatever drift-mitigation measures are

appropriate to their situation, and could

include use of particular application

technologies or techniques. Or it could

involve the use of shelter belts, and include

CONTROL

(1) No person may apply the substance in a

manner that results in adverse effects

beyond the boundary of the subject property.

(2) A person applying the substance must take

all practicable steps to avoid off-target

movement of the substance.

LABEL STATEMENT

(3) The following statement must appear on the

substance label:

The person applying this substance must not

cause adverse effects beyond the boundary

of the treated property, and must also avoid

adverse effects from spray drift occurring.

Mitigation measures employed must be

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Control


(but are not limited to) the New Zealand

Standard NZS8409:2004 Management of

Agrichemicals details various spray drift

reduction measures that can be implemented.

The use and details of the spray drift

mitigation measures implemented should be

included in the records of applications.

Accordingly, the requirements of controls T3

and E5 that specify the details included in the

records of use (regulation 6 of Hazardous

Substances (Classes 6, 8, and 9 Controls)

Regulations 2001) is amended to include

details of the spray drift mitigation measures

implemented.

recorded as part of the application records..



substance label includes the statement

specified in (3).




The following subclause is added to regulation

6(1) of the Hazardous Substances (Classes 6, 8,

and 9 Controls) Regulations 2001, after subclause

(g):

(h) details of measures taken to ensure that

there are no adverse effects beyond the

boundary of the subject property into an

adjoining property or sensitive area.

R-5 COVER GRANULES AFTER APPLICATION

In order to protect birds from exposure to

pesticide granules after application, granules

must be covered with soil immediately after

application.

CONTROL

(1) Any person applying the substance shall

ensure that, at the time of application, all

granules are completely covered with soil

such that granules are no longer visible.

LABEL STATEMENT



substance label specifies that all granules

must be completely covered with soil

immediately after application.




R-7 RESTRICTION ON METHOD OF

APPLICATION

Where restrictions on application method are

required to manage the exposure risk to

human health or to the environment,

application of a substance will be restricted to

specific application methods. This may include

specifying particular equipment that may be

used, locations or environments in which the

substance can be applied, or particular use

patterns to be avoided. For example:

aerial application may be prohibited;

use of a substance outdoors may be

CONTROL

(1) A person must not apply the substance,

unless applied in accordance with the

following:

[detail specific allowed equipment type or

method:

e.g. ground-based/non-dispersive;

ground-based application only;

Knapsack application only;

Remotely operated fogging equipment;

Treated wheat baits made from the

substance must be dyed blue or green].

LABEL STATEMENT


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Control


prohibited.

Use under this control may be limited to

delivery of the substance using automatic

systems. An automatic system is a delivery

system that is operated remotely and does not

require an operator to be present in the

application area during release of the

substance. This means that operators will not

be exposed to the substance during

application.

Additionally, this control will be used to specify

conditions or considerations for use of a

particular substance. In the particular instance

of maldison used to make insecticide wheat

baits, the treated wheat bait must be coloured

blue or green to reduce the risks posed to

birds by the bait substance.


substance label specifies the application

equipment or techniques that may be used to

apply the substance, in accordance with (1).




R-8 IDENTIFICATION AS AN

ORGANOPHOSPHATE OR CARBAMATE

SUBSTANCE

To ensure that users of the substance are

aware of the chemical class of the substance

being handled, the substance must be

labelled in a manner that clearly indicates the

chemical class to which the substance

belongs. This will identify to users that the

substance they are handling contains an

organophosphate or a carbamate, which will

alert the user to the risks of handling such

substances.

CONTROL/LABEL STATEMENT



substance label clearly states that the

substance is [an organophosphate][a

carbamate]-containing substance.




R-9

LABEL WARNING OF EFFECTS ON BEES

Where use of a substance may result in risks

of adverse effects on bees visiting treated

plants, to ensure that users of the substance

are aware of the toxic effects of the substance

to bees, an additional label statement is

required to highlight this concern and detail

circumstances to be avoided or restrictions

required to reduce the risks of use on bees.

Such measures could include avoidance of

application to flowering plants, or carrying out

application in the early morning or late

evening when bees are no longer active. This

control is more prescriptive than the

requirements of the default identification

regulations for class 9.4 ecotoxic substances.

CONTROL/LABEL STATEMENT



substance label shows the following

statement (or equivalent):

For HSNO class 9.4A substances:

This product is very toxic to bees. Do not apply

this product to any plant or tree likely to be visited

by bees—

(a) at the time of application; or

(b) immediately after application until spray has

dried; or

(c) in areas where bees are foraging.

For HSNO class 9.4B substances:

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This product is toxic to bees. Do not apply this

product to any plant or tree likely to be visited by

bees—



dried; or


For HSNO class 9.4C substances:

This product is harmful to bees. Do not apply this

product to any plant or tree likely to be visited by

bees—



dried; or





R-10 PERSONAL PROTECTIVE EQUIPMENT

If certain PPE or RPE is required to reduce

exposure risk whilst handling a substance, the

minimum levels of PPE will be specified as a

control.

CONTROL

(1) Any person who is mixing, loading or

applying the substance, or entering an

application area within the Restricted Entry

Interval (REI), must meet the following

minimum standards for personal protective

equipment by wearing the following:

Full Personal Protective Equipment (PPE):

Chemical resistant coveralls.

Chemical resistant gloves.

Chemical resistant footwear plus

socks.

Protective eyewear.

Chemical resistant headgear for

overhead exposures.

Respiratory Protective Equipment (RPE):

Respiratory protection equipment

appropriate to protect against respiratory

exposure to the substance in dust, mist, gas

or vapour forms of the substance.

(2) The requirements of (1) do not apply to a

person who is applying the substance using

a vehicle, and where that person is operating

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the vehicle from within a fully-enclosed cab

equipped with protective equipment to

prevent contact with, and inhalation of, the

substance.

LABEL STATEMENT

(3) Where PPE is prescribed under (1), a person

must not supply a hazardous substance to

any other person unless the substance label

specifies the PPE and RPE required to be

worn during the following lifecycle stages, in

accordance with (1): mixing, loading,

application, re-entry into treated areas.




R-11 NOTIFICATION

If application of a substance presents a risk to

bystanders or neighbours (for example from

off-target application), notification in advance

of application of the substance will be

required. The information required to be

provided is specified in the control, in addition

to timeframes for carrying out the notification.

Reasonable steps to avoid exposure may

include, but are not limited to, things like:

Closing windows and doors;

Moving laundry indoors prior to application

commencing;

Staying indoors during the application.

Diazinon granules could potentially be used

by approved handlers in private residential

settings (e.g. home gardens). As the approved

handler is unlikely to be present following

application, precautionary information should

be provided to the responsible person at the

property. This should communicate the

potential risks to household members and

make clear that individuals should not re-enter

treated areas until granules are no longer

present on the surface of treated areas.

CONTROL

(1) For wide-dispersive applications, no person

may apply, or engage another person to

apply, the substance unless that person has

given written notice of the proposed

application to any person likely to be directly

affected by the application, including

occupiers and owners of land, dwellings or

buildings or property that is immediately

abutting the application area.

(2) The notice referred to in subclause (1)

must—

(a) be given at least 2 working days but no

more than 4 weeks in advance of each

application; and

(b) specify the following:

(i) the location of application area that

the substance will be applied to;

(ii) the date and approximate duration

of each application;

(iii) the steps to be taken by the

notified parties to avoid exposure;

(iv) the name of the organisation/s

undertaking the application;

(v) contact details for the person in

charge of the application (phone,

email or postal address, including

a contact number for immediate

contact during application).

LABEL STATEMENT

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substance label shows that notification of

affected parties and neighbours, in

accordance with the requirements of (1) and

(2), must be carried out in advance of the

application.




For diazinon granules only

(HSR000175 / HSR000176)

PROVISION OF INFORMATION SHEET

(5) Where the substance is applied by an

approved handler in a private residential

setting (as an example, a home garden), the

approved handler must provide the person in

charge of the application area with a written

information sheet that contains the following

hazardous property and precautionary

information:

(a) identify:

(i) the name of the substance applied;

(ii) diazinon as the active ingredient;

and

(iii) the concentration of diazinon

contained in the substance;

(b) indicate that the substance may be

harmful if swallowed or in contact with

skin:

(c) advisory statements to ensure that

people and animals, particularly children

and pets, should not go onto or into

treated areas until:

(i) granules have been watered in:

and

(ii) granules are no longer visible:

(d) the symptoms or signs of injury or ill

health associated with each likely route

of exposure:

(e) an instruction to seek medical advice if

a person is exposed to, or consumes,

the substance; and

(f) a 24-hour emergency service telephone

number.

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(6) The written information sheet referred to in

(5) must comply with regulation 34(1), (2),

and (4) and regulation 35(1), (3), and (5) of

the Hazardous Substances (Identification)

Regulations 2001, but as if the distances

referred to in regulation 35(3) were a

distance of not less than 0.2 metres.

R-12 RESTRICTED ENTRY INTERVAL (REI)

A Restricted Entry Interval (REI) is the period

of time which must elapse after application of

a substance before entry into the treated area

is permitted without use of PPE or RPE. Entry

into an application area before the REI has

elapsed is only permitted if the same level of

PPE and RPE required for application of the

substance is worn. Where a substance is

used in an indoor setting (such as a

greenhouse, pack house or mushroom

house), the atmosphere may present an

exposure risk for a period of time after

application has been completed. In such

instances, the REI commences when the

ventilation of the building or structure

commences, which may be by mechanical or

passive means. The person in charge of the

place where a substance is applied is

responsible for ensuring that no-one enters

the application area until the end of the REI.

CONTROL

(1) The REI for this substance is [X] hours.

(2) The person in charge of the application area

shall ensure that no person who is

authorised to be there enters the application

area until the end of the REI.

(3) Despite (2), a person may enter the

application area before the end of the REI—

(a) if PPE and RPE is worn as if that

person is applying the substance; and

(b) if entering an indoor treated area, for

the purpose of carrying out tasks

associated with ventilation of the

building or structure.

LABEL STATEMENT



substance label shall show the requirements

for the REIs and corresponding PPE, in

accordance with (1) to (3).




R-13 APPROVED HANDLER

Approved handler requirements are used to

ensure that persons handling the substance

have the required level of knowledge and

expertise to safely use the substance.

Existing controls for approved hander

requirements for organophosphate and

carbamate substances have been modified to

different extents, such as only wide dispersive

use or use by a commercial contractor

requires an approved handler.

This control replaces the existing approved

handler requirements imposed on a substance

(if any). The substance must be under the

control of an approved handler, or securely

CONTROL

(1) The requirements of regulation 9 of

Hazardous Substances (Classes 6, 8, and 9

Controls) Regulations 2001, and regulations

4 to 6 of Hazardous Substances (Personnel

Qualifications) Regulations 2001 apply to this

substance.

LABEL STATEMENT



substance label specifies that the substance

must only be applied by an approved

handler, or under the direct supervision of an

approved handler.


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stored at all times, with the exception of

transportation of the substance.



The following regulation is inserted immediately

after regulation 9 of the Hazardous Substances

(Classes 6, 8, and 9 Controls) Regulations 2001:

9A Exception to approved handler requirement for

transportation of packaged pesticides

(1) Regulation 9 is deemed to be complied with

if:

(a) when this substance is being

transported on land—

(i) by rail, the person who drives the

rail vehicle that is transporting the

substance is fully trained in

accordance with the approved

safety system referred to in an

approved safety case under the

Railways Act 2005; and

(ii) other than by rail, the person who

drives, loads, and unloads the

vehicle that is transporting the

substance has a current

dangerous goods endorsement on

his or her driver licence; and

(iii) in all cases, Land Transport Rule:

Dangerous Goods 1999 (Rule

45001) is complied with; or

(b) when this substance is being

transported by sea, one of the following

is complied with:

(i) Maritime Rules: Part 24A –

Carriage of Cargoes – Dangerous

Goods (MR024A):

(ii) International Maritime Dangerous

Goods Code; or

(c) when this substance is being

transported by air, Part 92 of the Civil

Aviation Rules is complied with.

(2) Subclause (1)(a)—

(a) does not apply to a tank wagon or a

transportable container to which the

Hazardous Substances (Tank Wagons

and Transportable Containers)

Regulations 2004 applies; but

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(b) despite paragraph (a), does apply to an

intermediate bulk container that

complies with chapter 6.5 of the UN

Model Regulations.

(3) Subclause (1)(c)—

(a) applies to pilots, aircrew, and airline

ground personnel loading and

managing this substance within an

aerodrome; but

(b) does not apply to—

(i) the handling of this substance in

any place that is not within an

aerodrome; or

(ii) the loading and managing of this

substance for the purpose of aerial

spraying or dropping.

(4) In this regulation, UN Model Regulations

means the 17th revised edition of the

Recommendation on the transport of

Dangerous Goods Model Regulations,

published in 2011 by the United Nations.

The regulations apply to this substance as if the

following regulation was inserted immediately

after regulation 9A:

9B Exception to approved handler requirement for

aerial application of certain substances

Regulation 9 is deemed to be complied with if, in

the case of the aerial application of a hazardous

substance, the person who carries out the

application has a current pilot chemical rating in

accordance with Part 61 of the Civil Aviation

Rules.

R-14 SIGNAGE

This control will be imposed on use of a

substance when used indoors. Where a

substance is applied in an indoor

environment, and present a risk to persons

entering the location either during or after

application, a sign must be placed at the

entrances to the application area that has

been treated with the substance, to inform

people when safe entry into the location is

allowed. The responsibility for ensuring that

this occurs lies with the person in charge of

the application area and the person in charge

of the application.

CONTROL

(1) The person in charge of the application area

and the person in charge of the application of

the substance must ensure that signs are

erected outside of the application area, at

every routine point of entry into the

application area. Signs must be posted from

the start of commencement of application,

until the end of the application or Restricted

Entry Interval (REI), whichever is the later.

(2) Signs erected in accordance with subclause

(1) must –

(a) state that application is being carried

out using a substance that is toxic to

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humans; and

(b) state that entry into the application area

is not permitted unless PPE and RPE

are worn.

(3) Signs erected in accordance with subclauses

(1) and (2) must –

(a) comply with regulation 34(1), (2), and

(4) and regulation 35(1), (3), and (5) of

the Hazardous Substances

(Identification) Regulations 2001, but as

if the distances referred to in regulation

35(3) were a distance of not less than

10 metres; and

(b) identify the person in charge of the

application; and

(c) state the day on which the application

commenced; and

(d) state the time and date of the end of the

REI.

(4) Signs must be removed within 3 days (72

hours) of the end of the application or REI,

whichever is the later.

R-15 TRANSPORTATION RESTRICTION

Volatilization of toxic substances may

generate hazardous atmosphere within a

vehicle if the substance is not contained in

sealed packaging and transported inside of

the vehicle. In order to prevent exposure of

persons travelling in the vehicle, substance

transported in opened packaging must be

carried in a manner that will not expose

passengers in the vehicle to a hazardous

atmosphere. This control is in addition to the

default packaging and transportation controls.

No person shall transport the substance in a

vehicle unless the substance is contained in—

(a) a sealed, unopened sachet; or

(b) an airtight container.

Table 5. Interpretation

Term Definition

Any plant or

tree likely to be

visited by bees

Any plant or tree likely to be visited by bees includes flowering plants, flowering

trees and flowering weeds.

Application area Application area means the area within the boundary defined by the outer extremity

of a place to which the substance has been applied.

Automated

application

Automated application equipment means application equipment that does not

require an operator to be local to the application equipment to apply the substance.

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Term Definition

equipment This includes application equipment that requires manual relocation provided

substance is not being released from the equipment during the relocation process.

Chemical

resistant

Chemical resistant, with reference to PPE, means designed and constructed to be

resistant to the substance being handled and ensure that the person does not come

into contact with the substance.

Crop cycle

Crop cycle means the time covering all plant growth stages that occur—

(a) between planting and harvesting, or

(b) between crop harvests.

Person in

charge of

application

Person in charge of application means a person who is in effective control or

possession of the substance, and responsible for application of the substance from the

commencement of application until the end of the REI.

Person in

charge of

application area

Person in charge of application area means a person who is in effective control or

possession of the application area from the commencement of application until the end

of the REI.

Restricted Entry

Interval (REI)

Restricted Entry Interval (REI) means the period of time which must elapse from the

latter of—

(a) when the substance was last applied to the application area; or

(b) where the application area is within a building or enclosed structure, when

ventilation of the structure is commenced.

Sensitive area

Sensitive area means a place which may be adversely affected by application of a

substance. Sensitive areas include, but are not limited to, the following:

Places where members of the public are likely to be present and are unable

to readily evacuate themselves, such as a school, playground, early

childhood centre, prison, hospital or long-term care facility;

Water bodies, including public water supply catchments and intakes

catchment;

Sensitive habitats, such as wetlands, indigenous vegetation habitat areas and

reserves;

Public roads, public places and amenity areas.

14.17. The EPA staff consultation report and E&R report proposed imposing buffer zones as a mean

to minimise risks from spray drift. However, the Committee notes that buffer zones are not the

only means of spray drift management, and other options such as nozzle type, droplet size and

shelter belts are included in NZS8409:2004. The Committee is also aware that regional council

plans include controls intended to minimise the risk of adverse effects resulting from discharge of

agrichemicals beyond the boundary of an application area or property. The Committee does not

wish to contradict existing restrictions, and also wishes to provide flexibility for growers who need

to be able to accommodate varying operating conditions. Therefore, the Committee has

amended this control to be more in line with Regional Plans and NZS8409:2004 rather than

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specifying buffer zones. To help support enforceability, we are also requiring that growers record

details of measures taken to ensure there are no adverse effects beyond the boundary.

14.18. The Committee notes that the EPA staff reports did not include an exception for aerial

applicators with respect to the approved handler requirements. This exception is routinely applied

to hazardous substances approvals and considers that a person with a current pilot chemical

rating under the Civil Aviation Rules who carries out aerial application is deemed to have

complied with the approved handler requirements. Where the approved handler control has been

added to an approval through this reassessment, the Committee consider this exception should

apply.

14.19. As noted above Te Rūnanga o Ngāi Tahu asked for specific reference to signage to indicate

where OPC substances have been used so that persons gathering food from locations near OPC

treated areas are aware that OPCs have been used nearby. While the Committee is aware that

the EPA has imposed a similar control before, the circumstances of the use of OPCs are different

to other applications where the control has been imposed. For example, aquatic herbicides

usage (directly applied into water sources from which food plants are sources) or 1080 usage

(use in areas where the public has access). Advice from the EPA staff in reply to these

submissions made during the hearing noted that, in the case of OPCs, the effects of pesticide

usage beyond the application area are managed by other controls and regulations. The staff

also noted that there are practicalities associated with the use of signage that would prove

difficult, such as location of placement of signs and the duration that the signs should remain in

place. The Committee accept these practical considerations and have imposed other controls

that we consider address the submitter’s concerns.

14.20. The Committee notes that a number of submissions received commented on the variability of

approved handler training, with some expressing concern that the training was inadequate to

ensure approved handlers were fully competent and experienced to handle OPCs. The

Committee also notes that the EPA cannot directly influence the quality of training courses on

offer. There is no regulatory mandate requiring, for example, the EPA to approve training

courses. Training is available via a number of training providers and organisations, including test

certifiers, all of whom operate in a free market. This results in a diversity of training opportunities

from Industry Training Organisations who offer moderated, NZQA based unit standards, to

providers where there is no formal moderation or recognised qualification.

14.21. The EPA’s point of influence is via the test certifiers who assess the competency of a person

and their knowledge, skills and experience before issuing an approved handler test certificate. A

recently issued performance standard for test certifiers sets out a number of requirements that

must be followed and met for an approved handler test certificate to be issued.

14.22. The Committee recommends that the EPA continues to work with test certifiers to ensure the

full requirements of the Hazardous Substances and New Organisms (Personnel Qualifications)

Regulations 2001 are satisfied for the test certificate issued. In addition, we recommend that the

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EPA explores opportunities to establish better links with industry training organisations who offer

NZQA based courses and unit standards.

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15. Overall evaluation of significant adverse and positive effects

Introduction

15.1. The overall evaluation of risks, costs and benefits was carried out having regard to the tests in

clause 27 of the Methodology and section 29 of the Act.

15.2. Clause 34 of the Methodology sets out the approaches available to the Authority in evaluating

the combined impact of risks, costs and benefits i.e. weighing up the risks, costs and benefits.

15.3. Risks and benefits for each OPC under review are set out in Table 6 below.

Table 6. Overall evaluation of risks and benefits of OPC plant protection insecticides

OPC Critical uses Risks Benefits

Acephate Avocado, baby leaf,

citrus, biosecurity Negligible – medium

High (horticulture,

biosecurity)

Benomyl No substances containing benomyl are registered under the ACVM Act

Carbaryl Avocado, summerfruit,

biosecurity Negligible – medium

High (horticulture,

biosecurity)

Carbofuran No substances containing carbofuran are approved under HSNO

Carbosulfan No substances containing carbosulfan are registered under the ACVM Act

Chlorpyrifos

Arable, avocado,

cucurbit, kumara, onion,

other vegetables,

persimmon, potato,

processed vegetables,

strawberry, summerfruit,

sweetcorn, pasture,

fodder and forage,

biosecurity

Negligible – high High (horticulture,

pasture, biosecurity)

Chlorpyrifos-methyl

Export only – has economic benefits for the manufacturing company but does

not pose risks for New Zealand as it is not used outside of manufacturing

plant

Diazinon

Arable, avocado,

baby/salad leaf, carrot,

citrus, kumara,

peas/beans, strawberry,

processed tomato,

pasture, fodder and

forage, biosecurity

Negligible – high High (horticulture,


Dichlofenthion No substances containing dichlofenthion are approved under HSNO

Dichlorvos Biosecurity,

Export only Negligible High (biosecurity)

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Dimethoate Fodder and forage

(brassica); biosecurity Negligible – medium

High (fodder and

forage, biosecurity)

Ethion No substances containing ethion are approved under HSNO

Famphur No substances containing famphur are approved under HSNO

Fenamiphos Carrot/parsnip, potato,

biosecurity Negligible – high

High (horticulture,

biosecurity)

Fenitrothion No critical uses Negligible – medium Low

Isazofos No substances containing isazofos are approved under HSNO

Maldison (malathion)

Avocado, citrus,

kumara, pasture, fodder

and forage, biosecurity

Negligible – medium High (horticulture,


Methamidophos

Kumara, maize, onion,

potato, processed

tomato, processed

sweetcorn, tamarillo

Negligible – medium High (horticulture)

Methomyl

Baby/salad leaf,

greenhouse (tomato and

capsicum), strawberry

Negligible – medium High (horticulture)

Omethoate No substances containing omethoate are approved under HSNO

Oxamyl

Carrot/parsnip,

greenhouse (tomato and

capsicum)

Negligible – high High (horticulture)

Phorate

No critical uses

(diazinon a preferred

alternative)

Negligible – high Low

Phoxim No substances containing phoxim are registered under the ACVM Act

Pirimicarb

Arable, citrus, Chinese

greens, cucurbit, potato,

processed peas, beans

and tomatoes,

strawberry, summerfruit,

transplant nurseries,

vegetable brassica,

fodder and forage


fodder and forage)

Pirimiphos-methyl

Avocado, greenhouse

(tomato), grain silo,

persimmon, processed

vegetables, fodder and

forage


fodder and forage)

Prothiofos Grapes Negligible – high High (viticulture)

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Pyrazophos No substances containing pyrazophos are registered under the ACVM Act

Terbufos

Kumara, processed

peas/beans and carrots,

pasture, fodder and

forage

Negligible – medium High (kumara)

Pasture

15.4. The Committee identified substantial benefits from the use of OPCs on pasture, and the

associated fodder and forage sector. Pasture is New Zealand’s largest agricultural crop and also

supports the dairy, beef, lamb and deer industries. The estimated contribution of pasture to the

New Zealand economy is around $24 billion. These economic benefits have a flow on effect,

providing health benefits resulting from employment in farming and related industries and from

lower food prices if crop yields are not reduced due to lack of pest control.

15.5. In addition to the generic benefits of OPCs, the Committee also took note of the specific

benefits provided by some substances, in particular the critical need for diazinon for the control of

grass grub, for which there is a lack of effective alternative control options.

15.6. The Committee also identified risks for human health and the environment from the use of all

the OPCs used on pasture and/or fodder and forage, with the exception of maldison on pasture.

The highest risks were associated with the use of diazinon on pasture and fodder and forage,

and of fenamiphos on fodder and forage.

15.7. The Committee is of the view that in general the very high economic benefits provided by use

of OPCs in the pasture sector outweigh the adverse effects of these substances.

15.8. For two substances, fenitrothion and phorate, the benefits were estimated as low and

information from submitters indicates that other OPCs are used in preference by industry. The

Committee considers that the human and environmental risks from use of these two substances

outweigh any beneficial effects.

15.9. For diazinon, the Committee considers that while there is a fine balance between the risks and

benefits associated with the use of diazinon on pasture the significant benefit in being the only

effective control of grass grub coupled with the additional controls that the Committee are

imposing outweigh any risks associated with the continued use of diazinon in pasture production.

Horticulture

15.10. The Committee considered the horticulture and arable sectors as a whole, noting that while

some specific crops may be relatively small industries, in combination they are worth over $2.7

billion to the national economy, have regional benefits through providing employment and

contribute to the diversity of the New Zealand horticulture industry and domestic food supply.

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15.11. The Committee recognises that a range of OPCs are needed in the horticulture and arable

sectors to maintain productivity, and therefore considers the level of benefit from use of these

substances to be high. As well as the generic benefits of OPCs, the Committee notes that

diazinon is critical for the growth of many crops due to its effectiveness in the control of grass

grub and a range of other pests. The Committee also notes the high level of regional benefits

from the use of terbufos on kumara, a vegetable of special cultural significance to New Zealand

Māori.

15.12. As for pasture, the benefits associated with fenitrothion and phorate, the benefits were

estimated as low and information from submitters indicates that other OPCs are used in

preference by industry. The Committee considers that the human and environmental risks from

use of fenitrothion and phorate outweigh any beneficial effects.

15.13. For diazinon, fenamiphos, methamidophos and prothiofos, the Committee considers that there

is currently while there is a fine balance between the risks and benefits associated with the use

of these substances in horticulture the clear benefits of the use of these substances and the

increased controls via the new management regime we have imposed mean we are satisfied that

the benefits of the continued use of these substances outweigh the risks.

Home garden

15.14. The Committee recognises the benefits provided by home gardening. However, it considers

that the risks from use of OPCs in the home garden outweigh the benefits, in particular due to the

human health risks. There are alternatives available for all OPCs used in the home garden apart

from diazinon granules for grass grub and porina on lawns.

15.15. The Committee considers it is likely that many home gardeners do not fully appreciate the

acute health risks not only to themselves but to other household members, in particular children.

The Committee is particularly concerned about the potential for harm to children (including the

fetus) from home garden use given the increasing suggestive evidence of neurodevelopmental

effects from exposure to low levels of OPs insufficient to result in acute poisoning.

Biosecurity

15.16. The availability of OPCs for preventing, managing and eradicating pest incursions was

considered by the Committee to be of critical importance for maintaining New Zealand’s

biosecurity system. We note that OPCs are of particular value because their broad spectrum

means that they are typically one of the first options for rapidly dealing with new pests for which

the optimum pesticide for eradication is unknown.

15.17. As well as the generic benefits of OPCs, the Committee notes that dichlorvos and fenamiphos

are particularly important tools for use by for MPI. Dichlorvos strips are an essential tool for

surveillance in maintaining New Zealand’s freedom from economically damaging species of fruit

fly. The Committee considers that the human health and environmental risks associated with the

use of dichlorvos strips are negligible.

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15.18. Fenamiphos is used for the compulsory eradication of nematodes in imported nursery stock,

and there are currently no other prescribed alternatives. The EPA staff risk assessment indicated

that the use of fenamiphos is associated with medium risks for operators; however, the

Committee considers that the very high benefits it provides outweigh these risks.

Substances not in use in New Zealand

15.19. The reassessment includes 11 OPCs that either only have HSNO approvals as active

ingredients, or are included in products that are not registered under the ACVM Act as plant

protection products in New Zealand. In addition, EPA staff identified one substance containing

the active ingredients carbaryl, maldison and rotenone which has no ACVM approval. In all but

one case (chlorpyrifos-methyl) there are no known uses of these substances.

15.20. No formal risk assessment was conducted for these substances as they are not in use.

However, due to the inherent risks associated with OPCs, and the lack of benefit provided by

these particular substances as evidenced by the fact they are not used, the Committee considers

that the potential risks outweigh the benefits.

15.21. For chlorpyrifos-methyl, the active ingredient is used in a substance that is manufactured in

New Zealand for export only, and in a substance that can only be used in the manufacture of

other substances. Also included in the reassessment is a substance containing dichlorvos that is

manufactured in New Zealand for export only. The Committee considers that there are benefits

for the manufacturing company associated with these substances, while the risks to the New

Zealand population and environment from their manufacture and export only are expected to be

negligible.

Summary and conclusions

15.22. The Committee notes that use of OPC plant protection insecticides is associated with a number

of non-negligible adverse effects, and therefore the decision is made based on clause 27 of the

Methodology.

15.23. The risks are considered to outweigh the benefits for the following substances: benomyl,

carbofuran, carbosulfan, dichlofenthion, ethion, famphur, isazofos, omethoate, pyrazophos,

fenitrothion and phorate.

15.24. Given the very high benefits of the other OPCs included in this reassessment application

through their value to the New Zealand primary production industry and for biosecurity purposes,

it is the Committee’s view that, with the implementation of the revised management regime

requiring additional controls, the adverse effects can be managed to a level where the positive

effects outweigh the risks. This relates to use of the following substances for agricultural and

biosecurity purposes: acephate, carbaryl, chlorpyrifos, chlorpyrifos-methyl, diazinon, dichlorvos,

dimethoate, fenamiphos, maldison, methamidophos, methomyl, oxamyl, pirimicarb, pirimiphos-

methyl, prothiofos and terbufos.

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15.25. The Committee considers that there is currently a fine balance between the benefits and the

adverse effects for several of these substances: diazinon, fenamiphos, methamidophos,

prothiofos and terbufos. The Committee anticipates that there is the potential for the specific

benefits currently possessed by these substances to decline with the development of

alternatives. Therefore, once alternatives are developed and proven to be valid then it is likely

that the risks associated with these substances would outweigh their benefits.

15.26. Given the high risks associated with the use of these compounds, we consider that their use in

the longer term is undesirable. Research into safer alternatives is needed in order to enable them

to be replaced.

15.27. It is the Committee’s view that the significant risks from use of OPCs by home gardeners

outweigh the benefits of home garden use of OPCs.

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16. Recommendations

16.1. The Committee makes the following recommendations:

That further research from industry and related research institutes on safer

alternatives to OPC insecticides is urgently required, in particular on alternatives

to diazinon, fenamiphos, methamidophos, prothiofos and terbufos;

There is a need for routine acetylcholinesterase monitoring of workers exposed

to OPs following an appropriate monitoring regime. To encourage this the

Committee recommends that the EPA and Ministry of Business, Innovation and

Employment explore the feasibility of developing updated guidance on this

issue;

Industry should seek to fill the data gaps relating to dermal absorption, toxicity

and ecotoxicity identified in the EPA consultation report;

Funding should be made available for research to evaluate the impacts of

pesticides on native New Zealand species;

There is also a need for better surveillance on the impacts of OPCs on human

and environmental health;

Industry groups should consider the possibility of developing voluntary initiatives

or codes of practice in addition to those that already exist to help ensure

effective spray drift management;

The EPA should continue to work with test certifiers to ensure the full

requirements of the Hazardous Substances Personnel Qualifications

Regulations are satisfied for the test certificate issued;

The EPA should explore opportunities to establish better links with industry

training organisations who offer NZQA based courses and unit standards.

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17. Decision

17.1. Pursuant to sections 63 and 29 of the Act, the Committee has considered this application to

reassess organophosphate and carbamate plant protection insecticides.

The Committee determines that:

17.2. Based on consideration and analysis of the information provided on the possible effects of OPC

plant protection insecticides, in accordance with the Act and the Methodology and taking into

account the application of the default controls and the varied and additional controls, the

Committee is satisfied, for the reasons set out in this decision, that the positive effects (benefits)

associated with the use of plant protection insecticides containing a number of OPC substances

outweigh the adverse effects (risks and costs).

17.3. The application for importation and manufacture of these substances is approved, with the

controls listed in the Annex accompanying this decision. For those substances where the positive

and adverse effects are finely balanced, time limited approvals have been granted.

17.4. For two OPCs, fenitrothion and phorate, a time-limited approval of three years has been

selected. As the Committee has chosen to allow two years for the implementation of additional

controls, it does not consider it practical to apply additional controls for these substances.

17.5. There are also a number of substances included in the reassessment application for which the

adverse effects outweigh the positive effects. For these substances, the application for import or

manufacture of these substances is declined.

17.6. The Committee’s decision is summarised in Table 7.

Table 7. Summary of the Committee’s decision

Decision OPC

Retain approvals, with additional controls

Active ingredients and/or formulations relating to the

following OPCs:

Acephate

Carbaryl

Chlorpyrifos

Chlorpyrifos-methyl

Dichlorvos

Dimethoate

Maldison

Methomyl

Oxamyl

Pirimicarb

Pirimiphos-methyl

Time-limited approvals, with additional controls Active ingredients and/or formulations relating to the

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Decision OPC

following OPCs:

Diazinon (15 years)

Fenamiphos (10 years)

Methamidophos (10 years)

Prothiofos (10 years)

Terbufos (10 years)

Time-limited approvals, without additional

controls


following OPCs:

Fenitrothion (3 years)

Phorate (3 years)

Decline


following OPCs:

Benomyl

Carbofuran

Carbosulfan

Dichlofenthion

Ethion

Famphur

Isazofos

Omethoate

Phoxim

Pyrazophos

A formulation containing carbaryl, maldison

and rotenone

17.7. The substances have the hazard classifications set out in Appendix B.

17.8. For ease of reference, the additional controls for each substance are listed in Appendix E. The

full list of controls for each substance are listed in an Annex accompanying this decision.

Helen Atkins

Chair, Decision Making Committee

Environmental Protection Authority Date: 27 June 2013

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Amendment June 2014

Typographical corrections were made to the classifications of the following substance approvals in Appendix B: HSR000155 : The 6.8 classification was corrected to 6.8B. HSR000181 : The acute oral classification was corrected to 6.1D.

In the Controls Annex to the decision: Approval number HSR000181 had controls amended to

reflect the controls for a 6.1D classification.

HSR000201 : The 6.1E (inhalation) classification was removed and replaced with the 6.1E (aspiration) hazard. HSR000203: The flammability classification was corrected to 3.1C. These amendments are considered technical and therefore completed under section 67A of the HSNO Act.

Helen Atkins


Environmental Protection Authority Date: 2 July 2014

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Amendment July 2015

This decision was amended on 21 July 2015 to correct the following technical errors in the original

decision.

Amendment to provide clarity regarding application of control R-3 when used in situations when

the term “crop cycle” is not relevant (e.g. use on turf). In such circumstances, the application

frequency applies per year.

Appendix E has been amended, as denoted by a superscript “s67A”. This is a correction to a

technical error.

Additionally, the Controls Annex document for this decision has been updated to reflect this

amendment.

Kerry Laing


Environmental Protection Authority Date: 21 July 2015

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Appendix A: Substances considered in the reassessment

Substance description and known trade names HSNO Approval Number

Acephate (active) HSR002724

Soluble concentrate containing 195 g/litre acephate. Also contains ethylene

glycol

Trade name: Orthene Liquid

HSR000154

Water soluble powder containing 750 - 970 g/kg acephate

Trade names: Orthene WSG, Raider HSR000155

Emulsifiable concentrate containing 45 g/litre acephate and 8.8 g/litre

myclobutanil

Trade name: Shield

HSR000156

Emulsifiable concentrate containing 45 g/litre acephate and 39 g/litre triforine

Trade name: Saprene HSR000157

Emulsifiable concentrate containing 22.5 g/litre acephate and 19.5 g/litre

triforine

Trade name: McGregor’s Rose and Shrub Spray

HSR000158

Benomyl (active) HSR002816

Wettable powder containing 500 g/kg benomyl HSR000347

Substances containing carbaryl as the active ingredient1 -

Dustable powder containing 2 g/kg carbaryl, 20 g/kg maldison and 5 g/kg

rotenone HSR000185

Wettable powder containing 150 - 200 g/kg carbaryl and 150 - 200 g/kg

mancozeb HSR007696

Suspension concentrate containing 100 g/litre carbaryl

Trade name: Garden King Carbaryl Flowable HSR000441

Suspension concentrate containing 500 g/litre carbaryl (Substance A)

Trade name: Yates Carbaryl Liquid HSR000450

Wettable powder containing 115 g/kg carbaryl, 250 g/kg copper as copper

oxychloride and 284 g/kg sulphur

Trade name: Garden King Multipest

HSR000594

Suspension concentrate containing 500 g/litre carbaryl (Substance C)

Trade name: SEVIN FLO HSR000680

Suspension concentrate containing 500 g/litre carbaryl (Substance B)

Trade name: Carbaryl 50F HSR000681

Carbofuran (active) HSR002928

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Carbosulfan (active) HSR003451

Granular material containing 100 g/kg carbosulfan HSR000696

Substances containing chlorpyrifos as the active ingredient1 -

Granular material containing 100 g/kg chlorpyrifos

Trade name: SUSCON GREEN HSR000163

Wettable powder containing 500 g/kg chlorpyrifos

Trade names: Jolyn Chlor-P 50WP, Chlorpyrifos 50W HSR000165

Granular material containing 50 g/kg chlorpyrifos. Also contains xylene

Trade name: Pyrifos G HSR000170

Emulsifiable concentrate containing 480 g/litre chlorpyrifos

Trade name: Pychlorex 48EC HSR000171

Wettable powder containing 56.25 g/kg carbendazim, 93.75 g/kg chlorpyrifos

and 400 g/kg mancozeb

Trade name: Super Spectrum

HSR000173

Emulsifiable concentrate containing 450 - 500 g/litre chlorpyrifos

Trade names: Chlorfos 480, LORSBAN 50EC INSECTICIDE, Toppel, TOPPEL

500, Donaghys INSEC480, Chlorpyrifos 500EC, CHLOR-P 480EC,

HORTCARE CHLORPYRIFOS 50 EC

HSR000224

Emulsifiable concentrate containing 480 g/litre chlorpyrifos. Also contains

xylene

Trade name: Pyrinex Insecticide

HSR000225

Solid containing 50 - 55 g/kg chlorpyrifos HSR007698

Liquid containing 250 - 350 g/litre chlorpyrifos HSR100298

Rampage HSR100018

Chlorpyrifos-methyl (active) HSR004064

Liquid containing 500 - 600 g/litre chlorpyrifos methyl HSR100326

Liquid containing 400 - 500 g/litre chlorpyrifos methyl HSR100299

Substances containing diazinon as the active ingredient1 -

Emulsifiable concentrate containing 800 g/litre diazinon (Substance A)

Trade name: DIAZINON 800 HSR000174

Granular material containing 200 g/kg diazinon

Trade names: DIAZINON 20G, Gesapon 20G HSR000175

Granular material containing 50 - 54 g/kg diazinon

Trade names: NO Insects Lawnguard Prills, Yates Soil Insect Killer HSR000176

Wettable powder containing 500 g/kg of diazinon HSR000177

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Trade name: Diazinon 50W

Emulsifiable concentrate containing 200 g/litre diazinon HSR000178

Emulsifiable concentrate containing 500 g/litre diazinon and 25 g/litre

permethrin

Trade name: Averte EC

HSR000179

Emulsion (oil in water) containing 600 g/litre diazinon HSR007700

Emulsion (oil in water) containing 500 - 600 g/litre diazinon

Trade names: Hortcare Diazinon 500 EW, DEW 600, Zagro Diazinon 600EW,

Diazol Insecticide, Basudin 600 EW, Dew 500

HSR000180

Emulsifiable concentrate containing 800 g/litre diazinon (Substance B)

Trade name: Digrub HSR000181

Emulsifiable concentrate containing 95 g/litre diazinon

Trade name: Liquid Diazinon HSR000182

Emulsifiable concentrate containing 800 g/litre diazinon (Substance C)

Trade name: DIAZINON 800EC HSR000183

Emulsifiable concentrate containing 600 g/litre diazinon

Trade name: Diazonyl 60EC HSR000184

Diazamax 800

Trade name: Diazol 800 Insecticide HSR002481

Dichlofenthion (active) HSR003685

Substances containing dichlorvos as the active ingredient1 -

DDVP insecticide strip HSR000126

J72.03 HSR001757

Dimethoate (active) HSR002841

Emulsifiable concentrate containing 400 g/litre dimethoate

Trade name: Dimezyl 40EC HSR000188


Trade name: Garden King Rogor 100 HSR000191


Trade names: Perfekthion S, Perigen 500 Spray & Residual Insecticide HSR000193

Perfekthion S-1

Trade names: DIME, PERFEKTHION S, Rogor E HSR000965

Danadim

Trade name: Danadim Progress HSR100129

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Ethion (active) HSR002985

Famphur (active) HSR002847

Substances containing fenamiphos as the active ingredient2 -

Emulsifiable concentrate containing 400 g/litre fenamiphos HSR000198

Nemacur 400EC

Trade name: Nemacur HSR000956




Canyon HSR100282

Substances containing fenitrothion as the active ingredient1 -

Emulsifiable concentrate containing 1000 g/litre fenitrothion

Trade name: CATERKIL 1000 HSR000201

Isazofos (active) HSR002857

Substances containing maldison (malathion) as the active

ingredient1

-

Dustable powder containing 2 g/kg carbaryl, 20 g/kg maldison and 5 g/kg

rotenone HSR000185

Technical concentrate containing 950 g/litre maldison

Trade name: Malathion 95 Insecticide HSR000189

Emulsifiable concentrate containing 500 g/litre maldison

Trade name: MALATHION 50EC HSR000190

Malathion-treated wheat

Trade names: ‘CRICKOFF PRO’ cricket bait, Cricket Bait HSR100407

Methamidophos (active) HSR002863

Soluble concentrate containing 600 g/litre methamidophos (Substance B)

Trade name: Monitor HSR000203

Soluble concentrate containing 600 g/litre methamidophos (Substance A)

Trade names: Metafort 60SL, Methafos 600, Tamaron HSR000226

Substances containing methomyl as the active ingredient1 -

Soluble concentrate containing 200 g/litre methomyl

Trade names: ORION METHOMYL 200SL, DuPont Lannate L insecticide HSR000584

Armourcrop Insecticide HSR007761

Omethoate (active) HSR002842

Substances containing oxamyl as the active ingredient2 -

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Soluble concentrate containing 240 g/litre oxamyl

Trade name: DuPont Vydate L oxamyl insecticide/nematicide HSR000791

Phorate (active) HSR003058

Granular product containing 200 g/kg phorate

Trade names: Thimet 20G, Disect, CROP CARE PHORATE 20G HSR000210

Phoxim (active) HSR003195

Emulsifiable concentrate containing 500 g/litre phoxim HSR000217

Substances containing pirimicarb as the active ingredient2 -

Water dispersible granule containing 500 g/kg pirimicarb (Substance B)

Trade names: Aphidex WG Insecticide, Pirimisect, Prohive HSR000703

Water dispersible granule containing 500 g/kg pirimicarb (Substance A)

Trade name: PIRIMOR 50 HSR000704

Piritek HSR007884

Dovetail HSR008052

Substances containing pirimiphos-methyl as the active

ingredient1

-

Smoke generator containing 225 g/kg pirimiphos-methyl

Trade name: Actellic Smoke Generator HSR000186

Emulsifiable concentrate containing 25 g/litre permethrin and 475 g/litre

pirimiphos-methyl

Trade name: ATTACK

HSR000187

Emulsifiable concentrate containing 5 g/litre permethrin and 95 g/litre

pirimiphos-methyl

Trade name: Target

HSR000192

Attack HSR100602

Substances containing prothiofos as the active ingredient2 -

Emulsifiable concentrate containing 500 g/litre prothiofos

Trade name: Tokuthion HSR000200

Substances containing pyrazophos as the active ingredient2 -

Emulsifiable concentrate containing 300 g/litre pyrazophos HSR000215

Substances containing terbufos as the active ingredient2 -

Granular product containing 200 g/kg terbufos

Trade name: Counter 20 G HSR000216

1 The active ingredient currently has a HSNO approval and is used in plant protection insecticides and

formulations used for other purposes. The present reassessment does not include the active ingredient as it only includes the formulations used as plant protection insecticides.

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2 There is no HSNO approval for the active ingredient, but there are approvals for plant protection formulations

containing the active ingredient.

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June 2013

Appendix B: Classifications of the approvals under consideration

Table 1 Classification changes for the active ingredients

Active ingredient Classification changes

Acephate

Remove 6.7B

Change to 9.1B instead of 9.1D

Change 9.2 to ND instead of No

Carbaryl

6.1 (dermal) changed from 6.1D to No

Add 6.1D (inhalation)

9.2B changed to 9.2A

Chlorpyrifos Add 6.8B

Chlorpyrifos-methyl

Add 6.5B

Change 6.6, 6.7 and 6.8 from ND to No

Add 9.2D instead of ND

Diazinon 9.2B instead of 9.2D

Dichlorvos

6.1 (inhalation) changed from 6.1A to 6.1B

Add 6.3B, 6.4A, 6.6B

Add 9.2B instead of ND

Dimethoate

6.1 (oral) changed from 6.1C to 6.1D

6.1 (dermal) changed from 6.1D to 6.1E

Change 6.5B, 6.6 and 6.7 from ND to No

9.1B instead of 9.1A

9.2B instead of 9.2D

Fenamiphos Change 6.6 and 6.8 from ND to No

Change 9.2 from 9.2B to 9.2D

Fenitrothion

Change 6.1C (oral) to 6.1D

Change 6.1E (dermal) to 6.1C

Add 9.2D

Maldison (malathion) Add 6.5B

Add 9.2B

Methamidophos Add 8.2C and 8.3A

Methomyl Change 9.2A to 9.2B

Oxamyl Change 6.9B to 6.9A

Change 9.2A to 9.2D

Phorate Change 6.6 from ND to No

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Active ingredient Classification changes

Change 9.2A to 9.2B

Pirimicarb

Change 6.1 (dermal) from ND to No

Change 6.1 (inhalation) from 6.1B to 6.1C

Change 6.7 from ND to No

Change 9.4C to 9.4B

Pirimiphos-methyl Change 6.5B from ND to No

Add 9.2D

Prothiofos

Change 6.1 (dermal) from ND to No

Change 6.8 from No to ND

Change 9.4C to 9.4B

Terbufos Add 9.2C

Table 2: HSNO classifications of OPC substances for which approvals are to be retained

Substance description and

known Trade name Approval number HSNO hazard classification

Acephate (active) HSR002724 6.1D (oral), 6.8B, 6.9A, 9.1B,

9.3B, 9.4A


195 g/litre acephate. Also

contains ethylene glycol

Trade name: Orthene Liquid

HSR000154 6.1D (oral), 6.3A, 6.4A, 6.8A,

6.8C, 6.9A, 9.1D, 9.3C, 9.4B

Water soluble powder containing

750 - 970 g/kg acephate

Trade names: Orthene WSG,

Raider

HSR000155 6.1D (oral), 6.8B, 6.9A, 9.1D,

9.3B, 9.4A



and 8.8 g/litre myclobutanil

Trade name: Shield

HSR000156 6.8B, 6.9B, 9.1C, 9.3C, 9.4B



and 39 g/litre triforine

Trade name: Saprene

HSR000157

3.1D, 6.1E (oral), 8.2B, 8.3A,

6.8A, 6.8C, 6.9B, 9.1D, 9.3C,

9.4B


containing 22.5 g/litre acephate

and 19.5 g/litre triforine

Trade name: McGregor’s Rose

and Shrub Spray

HSR000158 6.1E (oral), 6.3A, 8.3A, 6.8A,

6.8C, 6.9B, 9.3C, 9.4C

http://www.pic.int/?ID=3920



http://www.novachem.co.nz/?ID=3923



http://www.firstfound.org/david%20miller.htm?ID=3925



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Wettable powder containing 150 -

200 g/kg carbaryl and 150 - 200

g/kg mancozeb

HSR007696

6.1D (oral), 6.4A, 6.5B, 6.7B,

6.9B (oral), 9.1A, 9.2B, 9.3C,

9.4B



Trade name: Garden King

Carbaryl Flowable

HSR000441

6.1D (oral), 6.1E (inhalation),

6.4A, 6.7B, 6.9B (oral), 9.1A,

9.2B, 9.3B, 9.4A



(Substance A)

Trade name: Yates Carbaryl

Liquid

HSR000450 6.1C (oral), 6.5B, 6.7B, 6.9B

(oral), 9.1A, 9.2A, 9.3B, 9.4A


g/kg carbaryl, 250 g/kg copper as

copper oxychloride and 284 g/kg

sulphur

Trade name: Garden King

Multipest

HSR000594

6.1D (oral), 6.4A, 6.5B, 6.7B,

6.9B (oral), 9.1A, 9.2B, 9.3C,

9.4B



(Substance C)

Trade name: SEVIN FLO

HSR000680 6.1C (oral), 6.5B, 6.7B, 6.9B,

9.1A, 9.2A, 9.3B, 9.4A



(Substance B)

Trade name: Carbaryl 50F

HSR000681 6.1C (oral), 6.3B, 6.4A, 6.7B,

6.9B, 9.1A, 9.2A, 9.3B, 9.4A


g/kg chlorpyrifos

Trade name: SUSCON GREEN

HSR000163 6.1D (oral), 6.1E (dermal), 6.8B,

6.9A, 9.1A, 9.3C, 9.4A


g/kg chlorpyrifos

Trade names: Jolyn Chlor-P

50WP, Chlorpyrifos 50W

HSR000165

6.1C (oral), 6.1C (dermal), 6.3B,

6.4A, 6.8B, 6.9A, 9.1A, 9.2B,

9.3A, 9.4A


g/kg chlorpyrifos. Also contains

xylene

Trade name: Pyrifos G

HSR000170

6.1D (oral), 6.1E (dermal), 6.3B

6.4A, 6.8B, 6.9B, 9.1A, 9.2C,

9.3B, 9.4A


containing 480 g/litre chlorpyrifos

Trade name: Pychlorex 48EC

HSR000171

3.1C, 6.1C (oral), 6.1E (dermal),

6.1D (inhalation), 6.3B, 6.4A,

6.8B, 6.9A, 9.1A, 9.2B, 9.3A,

9.4A

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Wettable powder containing

56.25 g/kg carbendazim, 93.75

g/kg chlorpyrifos and 400 g/kg

mancozeb

Trade name: Super Spectrum

HSR000173

6.1D (oral), 6.1D (dermal), 6.3B,

6.4A, 6.5B, 6.6A, 6.8A, 6.9B,

9.1A, 9.2C, 9.3B, 9.4A


containing 450 - 500 g/litre

chlorpyrifos

Trade names: Chlorfos 480,

LORSBAN 50EC INSECTICIDE,

Toppel, TOPPEL 500, Donaghys

INSEC480, Chlorpyrifos 500EC,

CHLOR-P 480EC, HORTCARE

CHLORPYRIFOS 50 EC

HSR000224

3.1D, 6.1C (oral), 6.1C (dermal),

6.1D (inhalation), 6.1E

(aspiration), 6.3B, 6.4A, 6.8B,

6.9A, 9.1A, 9.2B, 9.3A, 9.4A


containing 480 g/litre chlorpyrifos.

Also contains xylene

Trade name: Pyrinex Insecticide

HSR000225

3.1C, 6.1C (oral), 6.1C (dermal),

6.1D (inhalation), 6.3A, 6.4A,

6.8B, 6.9A, 9.1A, 9.2B, 9.3A,

9.4A

Solid containing 50 - 55 g/kg


6.1D (oral), 6.1E (dermal), 6.3B,

6.4A, 6.8B, 6.9B, 9.1A, 9.2C,

9.3B, 9.4A



6.1C (oral), 6.1C (dermal), 6.3B,

6.4A, 6.8B, 6.9A, 9.1A, 9.2B,

9.3A, 9.4A

Rampage HSR100018

6.1D (oral), 6.1C (dermal), 6.3B,

6.4A, 6.8B, 6.9A, 9.1A, 9.2C,

9.3B, 9.4A

Chlorpyrifos-methyl (active) HSR004064 6.1D (oral), 6.1D (dermal), 6.5B,

6.9A, 9.1A, 9.2D, 9.3C, 9.4A

Liquid containing 500-600 g/litre


6.1E (oral), 6.1E (dermal), 6.1E

(aspiration), 6.3B, 6.5B, 6.9A

(oral), 9.1A, 9.2D, 9.3C, 9.4A

Liquid containing 400-500 g/litre


6.1E (oral), 6.1E (dermal), 6.1E

(aspiration), 6.3B, 6.5B, 6.9A

(oral), 9.1A, 9.2D, 9.3C, 9.4A



(Substance A)

Trade name: DIAZINON 800

HSR000174

3.1C, 6.1D (oral), 6.1C (dermal),


6.7B, 6.8B, 6.9A, 9.1A, 9.2B,

9.3A, 9.4A


g/kg diazinon

Trade names: DIAZINON 20G,

HSR000175 6.1D (oral), 6.1E (dermal), 6.8B,

6.9A, 9.1A, 9.2D, 9.3A, 9.4A

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Gesapon 20G

Granular material containing 50 -

54 g/kg diazinon

Trade names: NO Insects

Lawngard Prills, Yates Soil Insect

Killer,

HSR000176 6.8B, 6.9B, 9.1A, 9.2D, 9.3A,

9.4A


g/kg of diazinon

Trade name: Diazinon 50W

HSR000177

6.1D (oral), 6.1D (dermal), 6.1D

(inhalation), 6.8B, 6.9A, 9.1A,

9.2B, 9.3A, 9.4A



3.1C, 6.1D (oral), 6.1E (dermal),

6.3B, 6.4A, 6.8B, 6.9A, 9.1A,

9.2B, 9.3A, 9.4A



and 25 g/litre permethrin

Trade name: Averte EC

HSR000179

3.1C, 6.1D (oral), 6.1D (dermal),



6.8B, 6.9A, 9.1A, 9.2B, 9.3A,

9.4A


600 g/litre diazinon HSR007700


(inhalation), 6.3A, 6.4A, 6.5B,

6.8B, 6.9A, 9.1A, 9.2B, 9.3A,

9.4A


500 - 600 g/litre diazinon

Trade names: Hortcare Diazinon

500 EW, DEW 600, Zagro

Diazinon 600EW, Diazol

Insecticide, Basudin 600 EW,

Dew 500

HSR000180


(inhalation), 6.8B, 6.9A, 9.1A,

9.2B, 9.3A, 9.4A



(Substance B)

Trade name: Digrub

HSR000181

3.1D, 6.1D (oral), 6.1D (dermal),


6.8B, 6.9A, 9.1A, 9.2B, 9.3A,

9.4A



Trade name: Liquid Diazinon

HSR000182

6.1E (oral), 6.1D (dermal), 6.3A,

6.4A, 6.5B, 6.8B, 6.9A, 9.1A,

9.2D, 9.3A, 9.4A



(Substance C)

Trade name: DIAZINON 800EC

HSR000183

6.1D (oral), 6.1C (dermal), 6.1D

(inhalation), 6.3A, 6.4A, 6.8B,

6.9A, 9.1A, 9.2B, 9.3A, 9.4A


containing 600 g/litre diazinon HSR000184 3.1D, 6.1D (oral), 6.1D (dermal),

6.1D (inhalation), 6.3B, 6.8B,

Page 94


June 2013



Trade name: Diazonyl 60EC 6.9A, 9.1A, 9.2B, 9.3A, 9.4A

Diazamax 800

Trade name: Diazol 800

Insecticide

HSR002481

3.1D, 6.1D (oral), 6.1D (dermal),

6.1D (inhalation), 6.3B, 6.8B,

6.9A, 9.1A, 9.2B, 9.3A, 9.4A

DDVP Insecticide Strip HSR000126

6.1D (oral), 6.1E (dermal), 6.1B

(inhalation), 6.3B, 6.4A, 6.5B,

6.6B, 6.7B, 6.9A, 9.1A, 9.2D,

9.3B, 9.4A

J72.03 HSR001757

6.1B (oral), 6.1C (dermal), 6.1B


6.6B, 6.7B, 6.9A, 9.1A, 9.2D,

9.3B, 9.4A

Dimethoate (active) HSR002841

6.1D (oral), 6.1E (dermal), 6.4A,

6.8B, 6.9A, 9.1B, 9.2B, 9.3A,

9.4A


containing 400 g/litre dimethoate

Trade name: Dimezyl 40EC

HSR000188

3.1C, 6.1D (oral), 6.1E

(aspiration), 6.4A, 6.8B, 6.9A,

9.1B, 9.2B, 9.3A, 9.4A



Trade name: Garden King Rogor

100

HSR000191

3.1D, 6.1D (oral), 6.1E


6.9A, 9.1B, 9.2D, 9.3B, 9.4A



Trade names: Perfekthion S,

Perigen 500 Spray & Residual

Insecticide

HSR000193

3.1C, 6.1D (oral), 6.1D (dermal),

6.3B, 6.4A, 6.8A, 6.9A, 9.1B,

9.2B, 9.3A, 9.4A

Perfekthion S-1

Trade names: DIME,

PERFEKTHION S, Rogor E

HSR000965

3.1C, 6.1D (oral), 6.1D (dermal),

6.4A, 6.8B, 6.9A, 9.1B, 9.2B,

9.3A, 9.4A

Danadim

Trade name: Danadim Progress HSR100129

3.1C, 6.1C (oral), 6.5A, 6.5B,

6.8B, 6.9A, 9.1B, 9.2B, 9.3A,

9.4A


containing 400 g/litre fenamiphos HSR000198

3.1C, 6.1B (oral), 6.1C (dermal),


6.8B, 6.9A (oral, dermal,

inhalation), 9.1A, 9.2D, 9.3A,

9.4A

Nemacur 400EC

Trade name: Nemacur HSR000956

3.1D, 6.1B (oral), 6.1C (dermal),


6.9A (oral, dermal, inhalation),

Page 95


June 2013



9.1A, 9.2D, 9.3A, 9.4A


3.1D, 6.1B (oral), 6.1C (dermal),


(aspiration), 6.3B, 6.4A, 6.9A

(oral, dermal, inhalation), 9.1A,

9.2D, 9.3A, 9.4A


3.1C, 6.1B (oral), 6.1C (dermal),




9.2D, 9.3A, 9.4A


6.1B (oral), 6.1D (dermal), 6.1D

(inhalation), 6.4A, 6.9A (oral,

dermal, inhalation), 9.1A, 9.2D,

9.3A, 9.4A

Canyon HSR100282

3.1C, 6.1B (oral), 6.1C (dermal),




9.2D, 9.3A, 9.4A


containing 1000 g/litre

fenitrothion

Trade name: CATERKIL 1000

HSR000201

3.1C, 6.1D (oral), 6.1C (dermal),

6.1E (aspiration), 6.3A, 8.3A,

6.5B, 6.8B, 6.9A, 9.1A, 9.2D,

9.3A, 9.4A

Technical concentrate containing

950 g/litre maldison

Trade name: Malathion 95

Insecticide

HSR000189

6.1D (oral), 6.1E (dermal), 6.1E


6.8B, 6.9A, 9.1A, 9.2B, 9.3B,

9.4A


containing 500 g/litre maldison

Trade name: MALATHION 50EC

HSR000190

3.1C, 6.1D (oral), 6.1E (dermal),

6.3B, 6.4A. 6.5B, 6.8B, 6.9A,

9.1A, 9.2B, 9.3B, 9.4A

Malathion-treated wheat

Trade names: ‘CRICKOFF PRO’

cricket bait, Cricket Bait

HSR100407 6.5B, 6.8B, 6.9B, 9.1A, 9.4B

Methamidophos (active) HSR002863

6.1B (oral), 6.1B (dermal), 6.1B

(inhalation), 8.2C, 8.3A, 6.9A,

9.1A, 9.2B, 9.3A, 9.4A



(Substance B)

Trade name: Monitor

HSR000203

3.1C, 6.1B (oral), 6.1B (dermal),

6.1B (inhalation), 8.2C, 8.3A,

6.9A, 9.1A, 9.2B, 9.3A, 9.4A

Page 96


June 2013





(Substance A)

Trade names: Metafort 60SL,

Methafos 600, Tamaron

HSR000226

3.1D, 6.1B (oral), 6.1B (dermal),

6.1B (inhalation), 8.2C, 8.3A,

6.9A, 9.1A, 9.2B, 9.3A, 9.4A


200 g/litre methomyl

Trade names: ORION

METHOMYL 200SL, DuPont

Lannate L insecticide

HSR000584

3.1B, 6.1C (oral), 6.1D (dermal),

6.1D (inhalation), 6.4A, 6.8B,

6.9A, 9.1A, 9.2D, 9.3B, 9.4A

Armourcrop Insecticide HSR007761 6.1D (oral), 6.4A, 6.8B, 6.9B,

9.1A, 9.3C, 9.4B


240 g/litre oxamyl

Trade name: DuPont Vydate L

oxamyl insecticide/nematicide

HSR000791

3.1C, 6.1B (oral), 6.1D (dermal),

6.1B (inhalation), 6.4A, 6.8B,

6.9A, 9.1B, 9.2D, 9.3A, 9.4A

Phorate (active) HSR003058

6.1A (oral), 6.1A (dermal), 6.1A

(inhalation), 6.8B, 6.9A (oral,

other), 9.1A, 9.2B, 9.3A,9.4A


g/kg phorate

Trade names: Thimet 20G,

Disect, CROP CARE PHORATE

20 G

HSR000210 6.1B (oral), 6.1A (dermal), 6.8B,

6.9A, 9.1A, 9.2C, 9.3A, 9.4B


containing 500 g/kg pirimicarb

(Substance B)

Trade names: Aphidex WG

Insecticide, Pirimisect, Prohive

HSR000703

6.1C (oral), 6.1D (inhalation),

6.3B, 6.4A, 6.5B, 6.9B, 9.1A,

9.3A, 9.4B


containing 500 g/kg pirimicarb

(Substance A)

Trade name: PIRIMOR 50

HSR000704

6.1C (oral), 6.1D (inhalation),

6.3B, 6.4A, 6.9B, 9.1A, 9.3A,

9.4B

Piritek HSR007884

6.1C (oral), 6.1D (inhalation).

6.4A, 6.5B, 6.9B, 9.1A, 9.3A,

9.4B

Dovetail HSR008052

3.1D, 6.1D (oral), 6.1D

(inhalation), 6.1E (aspiration),

8.2C, 8.3A, 6.5B, 6.9B, 9.1A,

9.2C, 9.3B, 9.4C

Smoke generator containing 225 HSR000186 6.1E (oral), 6.3B, 6.4A, 6.8B,

Page 97


June 2013



g/kg pirimiphos-methyl

Trade name: Actellic Smoke

Generator

6.9A, 9.1A, 9.3B, 9.4B




Trade name: ATTACK

HSR000187

3.1C, 6.1E (oral), 6.1E (dermal),

6.3B, 6.4A, 6.5A, 6.5B, 6.8B,

6.9A, 9.1A, 9.2D, 9.3A, 9.4A




Trade name: Target

HSR000192

3.1C, 6.1E (aspiration), 6.3B,

6.4A, 6.5A, 6.5B, 6.8B, 6.9A,

9.1A, 9.3B, 9.4B

Attack HSR100602

3.1D, 6.1E (oral), 6.1E (dermal),

6.1E (aspiration), 6.3A, 6.4A,

6.5A, 6.5B, 6.8B, 6.9A, 9.1A,

9.2D, 9.3A, 9.4A


containing 500 g/litre prothiofos

Trade name: Tokuthion

HSR000200

3.1C, 6.1D (oral), 6.1E (dermal),

6.3A, 6.4A, 6.5B, 6.9A, 9.1A,

9.3B, 9.4B


g/kg terbufos

Trade name: Counter 20 G

HSR000216

6.1B (oral), 6.1A (dermal), 6.1A

(inhalation), 8.2C, 8.3A, 6.8B,

6.9A, 9.1A, 9.3A, 9.4C

Page 98


June 2013

Appendix C: Acceptable daily intake/Potential daily exposure for food values for OPC active ingredients

Active ingredient ADI/PDEfood (mg/kg b.w./day)

Acephate 0.0012

Carbaryl 0.008

Chlorpyrifos 0.003

Diazinon 0.0002

Dichlorvos 0.001

Dimethoate 0.001

Fenamiphos 0.0001

Fenitrothion 0.002

Maldison 0.02

Methamidophos 0.0001

Methomyl 0.01

Oxamyl 0.002

Phorate 0.0005

Pirimicarb 0.035

Pirimiphos-methyl 0.02

Prothiofos 0.0001

Terbufos 0.0002

Page 99


June 2013

Appendix D: Overview of risks and benefits for OPCs

The following tables summarise the risks and benefits associated with use of each OPC in each

sector for which EPA staff performed modelling. This information was previously included in a

different form in the Summary and Analysis documents for each sector that accompanied the EPA

staff consultation report.

Page 100


June 2013

Acephate

Use Operator risk Re-entry worker

risk Bystander risk Aquatic risk Bird risk Overall benefit

Biosecurity Negligible Negligible Negligible Negligible Negligible High

Citrus Low Medium Low Negligible Medium Medium

Ornamentals Negligible Low Negligible Negligible Negligible Medium

Avocado Low Low/Medium Low Negligible Low/Medium Low

Berryfruit Negligible/Low Low Low Negligible Low Low

Cymbidiums Negligible/Medium Low Negligible Negligible Negligible Low

Lettuce & Salad Negligible Low Negligible Negligible Low Low

Brassica Negligible Low Low Negligible Medium Negligible

Field Tomato Negligible/Low Low Low Negligible Low Negligible

Potato Low Low Low Negligible Low Negligible

Tamarillo Low Medium Low Negligible Low Negligible

Page 101


June 2013

Carbaryl

Use Operator risk

Re-entry worker

risk Bystander risk Aquatic risk Bird risk Overall benefit

Avocados Negligible Low Low Low/Medium Negligible Low

Berryfruit Negligible Low Low Low Negligible Negligible

Biosecurity Unknown Negligible Negligible Negligible Negligible High

Field tomato Negligible Low Low Low Low Negligible

Maize Negligible Negligible Negligible Low Negligible Negligible

Ornamentals Negligible Low Negligible Low Negligible Medium

Persimmons Negligible Low Low Medium Low Negligible

Pipfruit Low Low Low Medium Negligible Medium

Stonefruit Low Low Low Low Low Medium

Strawberries Negligible Low Negligible Low Negligible Negligible

Sweetcorn Negligible Negligible Negligible Low Negligible Negligible

Tamarillo Low Low Low Medium Negligible Negligible

Turf Negligible Low/Negligible Low/Negligible Low/Negligible Low/Negligible Low

Page 102


June 2013

Chlorpyrifos


risk

Bystander


Overall

benefit

Arable Negligible Negligible Negligible Negligible/Low Negligible/Low/Medium Medium

Avocados Negligible Negligible Negligible/Low Low/Medium Negligible/Medium Medium

Beans & peas Negligible Negligible Negligible Low Medium Medium

Berryfruit Negligible Negligible Negligible Low Medium Low


Blackcurrants Negligible Negligible Negligible Low Medium Low

Blueberry Negligible Negligible Negligible Low Medium Low

Carrots Negligible Negligible Negligible Negligible/Low Low/Medium Low

Citrus Negligible Negligible Negligible Low Medium Negligible

Cucurbits Negligible Negligible Negligible Negligible Medium Negligible

Fodder and

forage Negligible Negligible Negligible Negligible/Low Low/Medium High

Grapes Negligible Negligible Negligible Low Medium Low

Kiwifruit Negligible Negligible Negligible Low Medium Negligible

Kumara Negligible Negligible Negligible Low Low Low

Page 103


June 2013

Maize Negligible Negligible Negligible Negligible/Low Low/Medium Medium

Onions Negligible Negligible Negligible Low Medium Medium

Ornamentals Negligible Negligible Negligible Negligible Negligible Medium

Pasture Negligible Negligible Negligible Negligible/Low Negligible/Low/Medium High

Persimmons Negligible Negligible Negligible Medium Medium Low

Pipfruit Negligible Negligible Negligible/Low Medium Medium/High Negligible

Potatoes Negligible Negligible Negligible Low Medium Medium

Stonefruit Negligible Negligible Negligible Low Medium Low

Strawberries Negligible Negligible Negligible Negligible Low Low

Sweetcorn Negligible Negligible Negligible Negligible/Low Low Low

Turf Negligible Negligible Negligible Negligible/Low Negligible/Medium High

Vegetables other Negligible Negligible Negligible Negligible Medium Low

Page 104


June 2013

Diazinon


risk

Bystander


Overall

benefit

Arable Low/Medium Negligible/Low/Medium Negligible/Low Negligible/Low/Medium High High

Avocadoes Negligible/Low Medium Low/Medium Medium High Medium

Beans & peas Low Medium Low Medium High Medium

Biosecurity Low/Medium Negligible Negligible/Low Negligible/Medium Negligible/High High

Brassica Negligible Low/Medium Low Low/Medium High Negligible

Carrots Negligible/Low/High Negligible/Medium Negligible/Low Negligible/Low High Medium

Citrus Low Medium Low Medium High Medium

Cymbidium Negligible/High Medium Negligible Negligible Negligible Low

Feijoa Low Medium Low Medium High Negligible

Field tomato Low Medium Low Medium High Low

Fodder and

forage

Negligible/Low/Medium

Negligible/Low/Medium

Negligible/Low Negligible/Low/Medium Medium/High High

Grapes Low Medium Low Low High Low*

Kiwifruit Low Medium Low Medium High Low*

Page 105


June 2013

*Used but not viewed as critical by sector

Kumara Low Negligible/Medium Negligible/Low Negligible/Low Medium/High Low

Lettuce Negligible Low/Medium Low Negligible/Low High Low

Maize Low/Medium Negligible/Low/Medium Negligible/Low Negligible/Medium High Medium

Onions Medium Medium Low Medium High Negligible

Ornamentals Negligible/Low Low/Medium Low Low High/Medium Medium

Passionfruit Low Medium Negligible Negligible High Low

Pasture Low/Medium Negligible/Low/Medium Negligible/Low Negligible/Low/Medium High/Medium High

Persimmons Low Medium Low Medium High Negligible

Pipfruit Low/Medium Medium Low Medium High High

Strawberries Negligible Medium Low Low Medium Low

Sweetcorn Low Low Low Medium High Low*

Tamarillo Low Medium Low Medium High Negligible

Turf Negligible/Low Negligible/Low/

Medium Negligible/Low Negligible/Low High High

Page 106


June 2013

Dichlorvos


risk

Bystander


Overall

benefit


Page 107


June 2013

Dimethoate


risk

Bystander


Overall

benefit

Arable Negligible Negligible Negligible Negligible Medium Medium

Berryfruit Negligible Negligible Low Negligible Medium Negligible

Biosecurity Unknown Negligible Negligible Negligible Negligible High

Carrots Negligible Negligible Negligible Negligible Medium Negligible

Fodder and

forage Negligible Negligible Negligible Negligible Medium High

Pipfruit Negligible Negligible Low Negligible Medium Negligible

Potatoes Negligible Negligible Negligible Negligible Medium Negligible

Strawberries Negligible Negligible Negligible Negligible Low Negligible

Page 108


June 2013

Fenamiphos


risk

Bystander


Overall

benefit

Biosecurity Medium Negligible Negligible Negligible Negligible High

Carrots Medium Medium Low Low High Medium

Fodder and

forage High Medium Medium Medium High Negligible

Kumara High Medium Medium Medium High Negligible

Ornamentals Low Medium Negligible Negligible Medium Medium

Potatoes High Medium Medium Medium High High

Turf Medium Medium Low Medium High Medium

Page 109


June 2013

Fenitrothion


risk

Bystander


Overall

benefit

Arable Negligible Low Low Low Medium Low

Fodder and

forage Low Low Low Low Medium Low

Pasture Negligible/Low Negligible/Low Negligible/Low Negligible/Low Low/Medium Low

Turf Negligible Low Low Negligible Medium Negligible

Page 110


June 2013

Maldison


risk

Bystander


Overall

benefit

Arable Negligible Negligible Negligible Negligible Low Negligible

Avocados Negligible Low Low Low/Medium Low Low

Biosecurity Negligible Negligible Negligible/Low Negligible, Low Negligible High

Brassica Negligible Negligible/Low Negligible Negligible Negligible/Low Negligible

Carrots Negligible Low Negligible Negligible Low Low

Citrus Negligible Low Negligible/Low Low Low Low

Fodder and

forage Negligible Low Negligible Negligible Medium Low

Grapes Negligible Low Negligible Negligible Low Negligible

Kumara Negligible Negligible Negligible Negligible Negligible Low

Pasture Negligible Negligible Negligible Negligible Negligible Low

Pipfruit Negligible Low Low Low Low Negligible

Turf Negligible Negligible Negligible Negligible Negligible Low

Page 111


June 2013

Methamidophos

*Used but not viewed as critical by sector


risk

Bystander


Overall

benefit

Beans & peas Low Medium Low Medium Medium Negligible

Brassica Low Medium Low Medium Medium Low*

Field tomato Medium Medium Low Medium Medium Low

Kumara Medium Medium Low Medium Medium Medium

Maize Low/Medium Medium Low Medium Medium Medium

Onions Medium Medium Low Medium Medium Medium

Ornamentals Medium Medium Negligible Negligible Medium Negligible

Potatoes Low, Medium Medium Low/Medium Medium Medium High

Sweetcorn Negligible/Low Low/Medium Low Medium Medium Low

Tamarillo Low/Medium Medium Low, Medium Medium Medium Low

Page 112


June 2013

Methomyl


risk

Bystander


Overall

benefit

Arable Low Negligible Low Negligible Medium Negligible

Beans & peas Negligible Low Low Negligible Medium Negligible

Berryfruit Negligible/Low Low Negligible/Low Negligible Medium Low

Blueberry Negligible Low Low Negligible Medium Low

Brassica Negligible Low Low Negligible Medium Negligible

Capsicum Negligible Low Negligible Negligible Negligible Low

Field tomato Negligible Low Low Negligible Medium Negligible

Grapes Negligible Low Low Negligible Low Negligible

Greenhouse

crops Negligible/Low Low Negligible Negligible Negligible Low

Lettuce Negligible Low Negligible Negligible Medium Negligible

Maize Low Negligible Low Negligible Medium Negligible

Strawberries Negligible Low Negligible/Low Negligible/Low Low/Medium Medium

Sweetcorn Negligible Negligible Low Negligible Medium Negligible

Page 113


June 2013

Oxamyl


risk

Bystander


Overall

benefit

Arable Negligible/Low Negligible/Low Low Negligible Medium/High Medium

Blackcurrants Negligible Low Low Negligible Medium Negligible

Capsicum Negligible Negligible Negligible Negligible Negligible Low

Carrots Low Medium Low Negligible High Low

Greenhouse

crops Negligible Negligible Negligible Negligible Negligible Low

Ornamentals Negligible Negligible Low Negligible Medium Medium

Pipfruit Low Medium Low Negligible High Negligible

Turf Low Medium Low Negligible High Medium

Page 114


June 2013

Phorate


risk

Bystander


Overall

benefit

Arable Low/Medium Negligible Negligible Negligible High Low

Carrots Low Negligible Negligible Negligible High Low

Cucurbits Negligible Negligible Negligible Negligible High Negligible

Fodder and

forage Low Negligible Negligible Negligible High Low

Kumara Low Negligible Negligible Negligible High Low

Ornamentals Low Negligible Negligible Negligible High Medium

Pasture Low Negligible Negligible Negligible High Low

Potatoes Low Negligible Negligible Negligible High Low

Strawberries Low Negligible Negligible Negligible High Negligible

Vegetables other Low Negligible Negligible Negligible High Low

Page 115


June 2013

Pirimicarb


risk

Bystander


Overall

benefit

Arable Negligible Negligible Negligible Negligible Low Medium

Beans & peas Negligible Negligible Negligible Negligible Low Low

Blackcurrants Negligible Negligible Negligible Negligible Low Low

Brassica Negligible Negligible Negligible Negligible Low Low

Citrus Negligible Negligible Negligible Negligible Medium Low

Cucurbits Negligible Negligible Negligible Negligible Low Low

Cymbidium Negligible Negligible Negligible Negligible Negligible Low

Field tomato Negligible Negligible Negligible Negligible Negligible Low

Fodder and

forage Negligible Negligible Negligible Negligible Low Low

Lettuce Negligible Negligible Negligible Negligible Low Low

Maize Negligible Negligible Negligible Negligible Low Medium

Pipfruit Negligible Negligible Negligible Low Medium Negligible

Potatoes Negligible Negligible/Low Negligible Negligible Low Low

Stonefruit Negligible Negligible Negligible Negligible Low Medium

Page 116


June 2013

Strawberries Negligible Negligible Negligible Negligible Low Low

Vegetables other Negligible Negligible Negligible Negligible Low Low

Page 117


June 2013

Pirimiphos-methyl


risk

Bystander


Overall

benefit

Arable Negligible Negligible Negligible Negligible Negligible Medium

Avocados Negligible Low Negligible/Low Medium Medium Medium


Brassica Negligible Negligible Negligible Low Medium Negligible

Citrus Negligible Low Negligible Medium Medium Negligible

Cymbidium Negligible/Low Negligible Negligible Negligible Negligible Low

Fodder and

forage Negligible Negligible Negligible Low/Medium Low/Medium High

Grapes Negligible Negligible Negligible Low Low Negligible

Greenhouse

crops Negligible Negligible Negligible Negligible Negligible Low

Kiwifruit Negligible Negligible Negligible Medium Medium Negligible

Ornamentals Negligible Low Negligible Low Low Medium

Persimmons Negligible Low Low Medium Medium Low

Page 118


June 2013

Prothiofos


risk

Bystander


Overall

benefit

Grapes Medium Medium Low Negligible Low High

Pipfruit High Medium Medium Medium Low Negligible

Page 119


June 2013

Terbufos


risk

Bystander


Overall

benefit

Arable Low Negligible Negligible Negligible Medium Negligible

Beans & peas Low Negligible Negligible Negligible Medium Negligible

Carrots Low Negligible Negligible Negligible Medium Negligible

Fodder and

forage Low Negligible Negligible Negligible Medium Low

Kumara Medium Negligible Negligible Negligible Medium Low

Maize Medium Negligible Negligible Negligible Medium Negligible

Pasture Low Negligible Negligible Negligible Medium Low

Sweetcorn Low Negligible Negligible Negligible Medium Negligible

Page 120


June 2013

Appendix E: Additional controls for plant protection insecticides containing OPCs

Active

Ingredient

Affected

approvals

Phase-in

of

controls

Decline /

Time-

limited

approval

R-3:

Application

parameters

R-4:

Spray drift

mitigation

R-5:

Cover

granules

R-7:

Method

restrictions

R-8:

Label:

OP /

carbamate

R-9:

Label:

bees

R-10:

PPE /

RPE

R-11:

Notification

R-12:

REI

R-13:

Appr

oved

Hand

ler

R-14:

Signage

R-15:

Transportation

Acephate HSR000154

HSR000155

HSR000156

HSR000157

HSR000158

2 years - Max. rate =

3500 g / ha;

Frequency =

3 times / crop

cycle

Y - Automatic

application

only (when

used indoors)

Y Y Full PPE;

RPE

Y 24 hours Y Y (when

used

indoors)

-

Benomyl HSR000347 - Decline - - - - - - - - - - - -

Carbaryl HSR007696

HSR000441

HSR000450

HSR000594

HSR000680

HSR000681


2700 g / ha.

Frequency =

3 times / crop

cycle

Y - - Y Y Full PPE;

RPE


used

indoors)

-

Carbaryl,

maldison

HSR000185 - Decline - - - - - - - - - - - -

Carbosulfan HSR000696 - Decline - - - - - - - - - - - -

Chlorpyrifos

(applied as

liquid)

HSR000165

HSR000171

HSR000173

HSR000224

HSR000225

HSR100298

HSR100018


1500 g / ha.

Y - - Y Y Full PPE Y – aerial

application

only

24 hours Y - -

Chlorpyrifos

(applied as

granules)

HSR000163

HSR000170

HSR007698


1500 g / ha.

Frequency =

1 time / crop

cycle

- Y - Y - Full PPE;

RPE

- - Y - -

Chlorpyrifos

methyl

HSR100326 - - - - - - - - - - - - - -

HSR100299 - - - - - - - - - - - - -

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Active

Ingredient

Affected

approvals

Phase-in

of

controls

Decline /

Time-

limited

approval

R-3:

Application

parameters

R-4:

Spray drift

mitigation

R-5:

Cover

granules

R-7:

Method

restrictions

R-8:

Label:

OP /

carbamate

R-9:

Label:

bees

R-10:

PPE /

RPE

R-11:

Notification

R-12:

REI

R-13:

Appr

oved

Hand

ler

R-14:

Signage

R-15:

Transportation

(Export-only

approval)

Diazinon

(applied as

liquid)

HSR000174

HSR000177

HSR000178

HSR000179

HSR007700

HSR000180

HSR000181

HSR000182

HSR000183

HSR000184

HSR002481

2 years 15 years Max. rate =

2400 g / ha.

Frequency =

2 times / crop

cycle

Y - Automatic

application

only (when

used indoors)

Y Y Full PPE;

RPE


used

indoors)

-

Diazinon

(applied as

granules)

HSR000175

HSR000176


3000 g / ha.

Frequency =

2 times / crop

cycle

Y - - Y - Full PPE;

RPE

Y – aerial and

home-garden

application by

AH

application

only

- Y - -

Dichlorvos HSR000126 2 years - - - - - - - Gloves;

use

tweezers

for

handling

unpackage

d strips.

- - - - Y

HSR001757

(Export-only

approval)

- - - - - - - - - - - - - -

Dimethoate HSR000188

HSR000191

HSR000193

HSR000965

HSR100129

2 years

-

400 g / ha

Frequency =

3 times / crop

cycle

Y - - Y Y Full PPE

RPE

Y 48 hours Y - -

Fenamiphos HSR000198

HSR000956

2 years; 10 years

Max. rate =

8000 g / ha.

Y - Prohibit aerial

application

Y Y Full PPE;

RPE

Y 48 hours Y - -

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June 2013

Active

Ingredient

Affected

approvals

Phase-in

of

controls

Decline /

Time-

limited

approval

R-3:

Application

parameters

R-4:

Spray drift

mitigation

R-5:

Cover

granules

R-7:

Method

restrictions

R-8:

Label:

OP /

carbamate

R-9:

Label:

bees

R-10:

PPE /

RPE

R-11:

Notification

R-12:

REI

R-13:

Appr

oved

Hand

ler

R-14:

Signage

R-15:

Transportation

HSR002480

HSR007769

HSR007894

HSR100282

Frequency =

1 time / crop

cycle

Fenitrothion HSR000201 - 3 years - - - - - - - - - - - -

Maldison /

malathion

HSR000189

2 years - - - - Only for use

in making

baits;

Baits must be

dyed blue or

green.

Y - Full PPE;

RPE

Y - Y -

HSR000190


4500 g / ha.

Frequency =

2 times / crop

cycle

Y - - Y Y Full PPE;

RPE

Y 24 hours Y - -

HSR100407 2 years - - - - - Y - Full PPE;

RPE

- - Y - -

Methamidop

hos

HSR000203

HSR000226


900 g / ha.

Y - - Y Y Full PPE;

RPE

Y 48 hours Y - -

Methomyl HSR000584

HSR007761


480 g / ha.

Y - Indoor use

excludes

handgun

Y Y Full PPE;

RPE

Y – for

outdoor use

24 hours

(boom, aerial

or knapsack

application

rates ≤300 g

/ ha)

48 hours (all

other

application

patterns)

Y Y (when

used

indoors)

-

Oxamyl HSR000791 2 years - Max. rate =

6720 g / ha.

Y - Prohibit aerial

application;

Automatic

application

only (when

used indoors)

Y Y Full PPE;

RPE

Y – for

outdoor use

24 hours

(for all

application

methods

except

dosing via

irrigation

system, or

when

Y - -

Page 123


June 2013

Active

Ingredient

Affected

approvals

Phase-in

of

controls

Decline /

Time-

limited

approval

R-3:

Application

parameters

R-4:

Spray drift

mitigation

R-5:

Cover

granules

R-7:

Method

restrictions

R-8:

Label:

OP /

carbamate

R-9:

Label:

bees

R-10:

PPE /

RPE

R-11:

Notification

R-12:

REI

R-13:

Appr

oved

Hand

ler

R-14:

Signage

R-15:

Transportation

applied

directly to

soil before

crop foliage

has

developed)

Phorate HSR000210 - 3 years - - - - - - - - - - - -

Phoxim HSR000217 - Decline - - - - - - - - - - - -

Pirimicarb HSR000703

HSR000704

HSR007884

HSR008052

2 years - - Y - - Y Y Full PPE - 24 hours Y - -

Pirimiphos-

methyl

HSR000187

HSR000192

HSR100602

2 years - 1425 g / ha.

Frequency =

4 time / crop

cycle

Y - Indoor use

excludes

handgun.

Y Y Full PPE;

RPE

Y – for

outdoor use

12 hours Y Y (when

used

indoors)

-

Pirimiphos-

methyl

(applied as a

smoke

generator)

HSR000186

2 years - - - - - Y - Full PPE;

RPE

- 12 hours Y Y (when

used

indoors)

-

Prothiofos HSR000200 2 years 10 years Max. rate =

500 g / ha.

Frequency =

1 time / crop

cycle

Y - Prohibit aerial

application

Y Y Full PPE;

RPE

Y 48 hours Y - -

Pyrazophos HSR000215 - Decline - - - - - - - - - - - -

Terbufos HSR000216 - 10 years Max. rate =

1500 g / ha.

- Y - Y - Full PPE;

RPE

- - Y - -

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Appendix F: Names of those who made oral presentations at the hearings

Submission number Submitter

Wellington (4 March

2013)

102661 John Liddle, Nursery and Garden Industry Association of New Zealand

102680 Roger Parton and colleagues, Rural Contractors New Zealand

102678 Matthew Dolan, New Zealand Agrichemical Education Trust

102671 Chris Houston, Beef and Lamb New Zealand; Catharine Sayer, Deer

Industry New Zealand

102673 Warren Hughes, Megan Dymond and Ken Glassey, Ministry for Primary

Industries

102659; 102660 Bill Brett, on behalf of himself, 13 independent garden centres and

individual home gardeners

102670 Julian Williams, Waikato Tainui River Trust

102676 Simon Terry, Sustainability Council

102672 William Rolleston, Federated Farmers of New Zealand

102684 Oliver Sutherland, Te Rūnanga o Ngāi Tahu

Auckland (7 March 2013)

102785 Greg Mitchell, DuPont

102681 Alan Cliffe, Nufarm New Zealand Ltd

102655 Roelf Schreuder, Gourmet Paprika

102666 Nerandra Patel, Gourmet Blueberries

102664 Jack Craw, Auckland Council

102663 Sam Weiss, Bay of Plenty Regional Council

102658 Meriel Watts, Pesticide Action Network Aotearoa New Zealand (PAN

ANZ)

102665 Brian Smith, Animal Remedy and Plant Protectant Association (ARPPA)

102679 Richard Donald

102675 Colin Sharpe, Dow AgroSciences

102662 Nikki Johnson, Market Access Solutionz

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Appendix G: Decision path for the reassessment of OPC plant protection insecticides

Context

This decision path describes the decision-making process for the application to import or manufacture

OPC plant protection insecticides. This application is made under section 63 (Reassessment) of the

HSNO Act, and determined under section 29 of the Act.

Introduction

The purpose of the decision path is to provide the HSNO decision maker16 with guidance so that all

relevant matters in the HSNO Act and the Methodology have been addressed. It does not attempt to

direct the weighting that the HSNO decision maker may decide to make on individual aspects of an

application.

In this document ‘section’ refers to sections of the HSNO Act, and ‘clause’ refers to clauses of the

Methodology.

The decision path has two parts –

Flowchart (a logic diagram showing the process prescribed in the Methodology and the HSNO Act

to be followed in making a decision), and

Explanatory notes (discussion of each step of the process).

Of necessity the words in the boxes in the flowchart are brief, and key words are used to summarise

the activity required. The explanatory notes provide a more comprehensive description of each of the

numbered items in the flowchart, and describe the processes that should be followed to achieve the

described outcome.

16 The HSNO decision maker refers to either the EPA Board or any committee or persons with delegated authority from

the Board.

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For proper interpretation of the decision path it is important to work through the flowchart in

conjunction with the explanatory notes.

1

Review the content of the

application and all relevant

information

2

Is this information sufficient

to proceed?

5

Identify the composition of the substance,

classify the hazardous properties of the

substance, and determine default controls

6

Identify all risks, costs and benefits that are

potentially non-negligible

7

Assess each risk assuming controls in place.

Add, substitute or delete controls in

accordance with Clause 35 and Sections77,

77A, 77B

8

Undertake combined consideration of all risks

and costs, cognisant of proposed controls

9

Are all risks and costs with controls in

place negligible?

10

Review controls for cost-effectiveness in

accordance with clause 35 and sections 77,

77A, 77B

11

Is it evident that benefits outweigh

costs?

16

Confirm and set controls

Approve

3

Seek additional

information

4

Sufficient?

Do not

approve

12

Establish position on risk averseness

and appropriate level of caution

13

Review controls for cost-effectiveness

in accordance with clause 35 and

sections 77, 77A, 77B

14

Assess benefits

15

Taking into account controls,

do positive effects outweigh adverse

effects?

Decline

Clause 27

Clause 26

No

No

No

No

Yes

Yes

Yes

Yes

Yes

No

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Explanatory Notes

Item 1: Review the content of the application and all relevant information

Review the application, the E&R Report, and information received from experts and that provided in

submissions (where relevant) in terms of section 28(2) of the Act and clauses 8, 15, 16 and 20 of the

Methodology.

Item 2: Is this information sufficient to proceed?

Review the information and determine whether or not there is sufficient information available to

make a decision.

The Methodology (clause 8) states that the information used by the HSNO decision maker in

evaluating applications shall be that which is appropriate and relevant to the application. While the

HSNO decision maker will consider all relevant information, its principal interest is in information

which is significant to the proper consideration of the application; i.e. information which is “necessary

and sufficient” for decision-making.

Item 3: (if ‘no’ from item 2) Seek additional information

If there is not sufficient information then additional information may need to be sought from the

applicant, the EPA staff or other parties/experts under section 58 of the Act (clause 23 of the

Methodology).

Item 4 Sufficient?

When additional information has been sought, has this been provided, and is there now sufficient

information available to make a decision?

If the HSNO decision maker is not satisfied that it has sufficient information for consideration, then

the application must be declined under section 29(1)(c).

Item 5:

(If ‘yes’ from item 2 or from item 4) Identify the composition of the substance, classify the

hazardous properties, and determine default controls

Identify the composition of the substance, and establish the hazard classifications for the identified

substance.

Determine the default controls for the specified hazardous properties using the regulations ‘toolbox’.

Item 6: Identify all risks, costs and benefits that are potentially non-negligible17

Costs and benefits are defined in the Methodology as the value of particular effects (clause 2).

However, in most cases these ‘values’ are not certain and have a likelihood attached to them. Thus

costs and risks are generally linked and may be addressed together. If not, they will be addressed

separately. Examples of costs that might not be obviously linked to risks are direct financial costs

that cannot be considered as ‘sunk’ costs (see footnote 1). Where such costs arise and they have a

market economic effect they will be assessed in the same way as risks, but their likelihood of

occurrence will be more certain (see also item 11).

Identification is a two-step process that scopes the range of possible effects (risks, costs and

benefits).

17 Relevant effects are marginal effects, or the changes that will occur as a result of the substance being available.

Financial costs associated with preparing and submitting an application are not marginal effects and are not effects of the substance(s) and are therefore not taken into account in weighing up adverse and positive effects. These latter types of costs are sometimes called ‘sunk’ costs since they are incurred whether or not the application is successful.

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Step 1:

Identify all possible risks and costs (adverse effects) and benefits (positive effects)

associated with the approval of the substance(s), and based on the range of areas

of impact described in clause 9 of the Methodology and sections 5 and 6 of the

Act18. Consider the effects of the substance through its lifecycle (clause 11) and

include the likely effects of the substance being unavailable (sections 29(1)(a)(iii)

and 29(1)(b)(iii)).

Relevant costs and benefits are those that relate to New Zealand and those that

would arise as a consequence of approving the application (clause 14).

Consider short term and long term effects.

Identify situations where risks and costs occur in one area of impact or affect one

sector and benefits accrue to another area or sector; that is, situations where risks

and costs do not have corresponding benefits.

Step 2: Document those risks, costs and benefits that can be readily concluded to be

negligible19, and eliminate them from further consideration.

Note that where there are costs that are not associated with risks some of them

may be eliminated at this scoping stage on the basis that the financial cost

represented is very small and there is no overall effect on the market economy.

Item 7: Assess each risk assuming controls in place. Add, substitute or delete controls in

accordance with clause 35 and sections 77, 77A and 77B of the Act.

The assessment of potentially non-negligible risks and costs should be carried out in accordance

with clauses 12, 13, 15, 22, 24, 25, and 29 to 32 of the Methodology. The assessment is carried out

with the default controls in place.

Assess each potentially non-negligible risk and cost estimating the magnitude of the effect if it

should occur and the likelihood of it occurring. Where there are non-negligible financial costs that

are not associated with risks then the probability of occurrence (likelihood) may be close to 1.

Relevant information provided in submissions should be taken into account.

The distribution of risks and costs should be considered, including geographical distribution and

distribution over groups in the community, as well as distribution over time. This information should

be retained with the assessed level of risk/cost.

This assessment includes consideration of how cautious the HSNO decision maker will be in the

face of uncertainty (section 7). Where there is uncertainty, it may be necessary to estimate

scenarios for lower and upper bounds for the adverse effect as a means of identifying the range of

uncertainty (clause 32). It is also important to bear in mind the materiality of the uncertainty and

how significant the uncertainty is for the decision (clause 29(a)).

Consider the HSNO decision maker’s approach to risk (clause 33 of the Methodology) or how risk

averse the HSNO decision maker should be in giving weight to the residual risk, where residual risk

is the risk remaining after the imposition of controls.

See EPA report ‘Approach to Risk’ for further guidance20.

Where it is clear that residual risks are non-negligible and where appropriate controls are available,

18 Effects on the natural environment, effects on human health and safety, effects on Maori culture and traditions, effects

on society and community, effects on the market economy. 19 Negligible effects are defined in the Annotated Methodology as “Risks which are of such little significance in terms of

their likelihood and effect that they do not require active management and/or after the application of risk management can be justified by very small levels of benefits.

20 http://www.epa.govt.nz/Publications/Approach-to-Risk.pdf

http://oscar/General.aspx

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add substitute or delete controls in accordance with sections 77 and 77A of the Act to reduce the

residual risk to a tolerable level. If the substance has toxic or ecotoxic properties, consider setting

exposure limits under section 77B. While clause 35 is relevant here, in terms of considering the

costs and benefits of changing the controls, it has more prominence in items 10 and 13

If changes are made to the controls at this stage then the approach to uncertainty and the approach

to risk must be revisited.

Item 8: Undertake combined consideration of all risks and costs, cognisant of proposed controls

Once the risks and costs have been assessed individually, if appropriate consider all risks and costs

together as a ‘basket’ of risks/costs. This may involve combining groups of risks and costs as

indicated in clause 34(a) of the Methodology where this is feasible and appropriate, or using other

techniques as indicated in clause 34(b). The purpose of this step is to consider the interactions

between different effects and determine whether these may change the level of individual risks.

Item 9: Are all risks with controls in place negligible?

Looking at individual risks in the context of the ‘basket’ of risks, consider whether all of the residual

risks are negligible.

Item 10:

(from item 9 - if ‘yes’) Review controls for cost-effectiveness in accordance with clause 35

and sections 77, 77A and 77B

Where all risks are negligible the decision must be made under clause 26 of the Methodology.

Consider the practicality and cost-effectiveness of the proposed individual controls and exposure

limits (clause 35). Where relevant and appropriate, add, substitute or delete controls whilst taking

into account the view of the applicant, and the cost-effectiveness of the full package of controls.

Item 11: Is it evident that benefits outweigh costs?

Risks have already been determined to be negligible (item 9). In the unusual circumstance where

there are non-negligible costs that are not associated with risks they have been assessed in item 7.

Costs are made up of two components: internal costs or those that accrue to the applicant, and

external costs or those that accrue to the wider community.

Consider whether there are any non-negligible external costs that are not associated with risks.

If there are no external non-negligible costs then external benefits outweigh external costs. The

fact that the application has been submitted is deemed to demonstrate existence of internal or

private net benefit, and therefore total benefits outweigh total costs21. As indicated above, where

risks are deemed to be negligible, and the only identifiable costs resulting from approving an

application are shown to accrue to the applicant, then a cost-benefit analysis will not be required.

The act of an application being lodged will be deemed by the HSNO decision maker to indicate that

21

Technical Guide ‘Decision making’ section 4.9.3. Where risks are negligible and the costs accrue only to the applicant, no explicit cost benefit analysis is required. In effect, the HSNO decision maker takes the act of making an application as evidence that the benefits outweigh the costs. See also Protocol Series 1 ‘General requirements for the Identification and Assessment of Risks, Costs, and Benefits’.

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the applicant believes the benefits to be greater than the costs.

However, if this is not the case and there are external non-negligible costs then all benefits need to

be assessed (via item 14).

Item 12:

(if ‘no’ from item 9) Establish position on risk averseness and appropriate level of caution

Although ‘risk averseness’ (approach to risk, clause 33) is considered as a part of the assessment of

individual risks, it is good practice to consolidate the view on this if several risks are non-negligible.

This consolidation also applies to the consideration of the approach to uncertainty (section 7).

Item 13: Review controls for cost-effectiveness in accordance with clause 35 and sections 77, 77A

and 77B

This constitutes a decision made under clause 27 of the Methodology (taken in sequence from items

9 and 12).

Consider whether any of the non-negligible risks can be reduced by varying the controls in

accordance with sections 77 and 77A of the Act, or whether there are available more cost-effective

controls that achieve the same level of effectiveness (section 77A(4)(b) and clause 35(a)).

Where relevant and appropriate, add, substitute or delete controls whilst taking into account the

views of the applicant (clause 35(b)), and making sure that the total benefits that result from doing

so continue to outweigh the total risks and costs that result.

As for item 7, if the substance has toxic or ecotoxic properties, consider exposure limits under

section 77B.

Item 14: (if ‘no’ from item 11 or in sequence from item 13) Assess benefits

Assess benefits or positive effects in terms of clause 13 of the Methodology.

Since benefits are not certain, they are assessed in the same way as risks. Thus the assessment

involves estimating the magnitude of the effect if it should occur and the likelihood of it occurring.

This assessment also includes consideration of the HSNO decision maker’s approach to uncertainty

or how cautious the HSNO decision maker will be in the face of uncertainty (section 7). Where there

is uncertainty, it may be necessary to estimate scenarios for lower and upper bounds for the positive

effect.

An understanding of the distributional implications of a proposal is an important part of any

consideration of costs and benefits, and the distribution of benefits should be considered in the

same way as for the distribution of risks and costs. The HSNO decision maker will in particular look

to identify those situations where the beneficiaries of an application are different from those who

bear the costs22. This is important not only for reasons related to fairness but also in forming a view

of just how robust any claim of an overall net benefit might be. It is much more difficult to sustain a

claim of an overall net benefit if those who enjoy the benefits are different to those who will bear the

costs. Thus where benefits accrue to one area or sector and risks and costs are borne by another

area or sector then the HSNO decision maker may choose to be more risk averse and to place a

higher weight on the risks and costs.

22 This principle derives from Protocol Series 1, and is restated in the Technical Guide ‘Decision making’.

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As for risks and costs, the assessment is carried out with the default controls in place.

Item 15: Taking into account controls, do positive effects outweigh adverse effects?

In weighing up positive and adverse effects, consider clause 34 of the Methodology. Where

possible combine groups of risks, costs and benefits or use other techniques such as dominant risks

and ranking of risks. The weighing up process takes into account controls proposed in items 5, 7,

10 and/or 13.

Where this item is taken in sequence from items 12, 13 and 14 (i.e. risks are not negligible) it

constitutes a decision made under clause 27 of the Methodology.

Where this item is taken in sequence from items 9, 10, 11 and 14 (i.e. risks are negligible, and there

are external non-negligible costs) it constitutes a decision made under clause 26 of the

Methodology.

Item 16:

(if ‘yes’ from items 11 or 15) Confirm and set controls

Controls have been considered at the earlier stages of the process (items 5, 7, 10 and/or 13). The

final step in the decision-making process brings together all the proposed controls, and reviews for

overlaps, gaps and inconsistencies. Once these have been resolved the controls are confirmed.

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Appendix H: Abbreviations and acronyms

Term Definition

Acute Adverse effect that occurs after a single exposure which usually lasts for a short time.

ADE Acceptable Daily Exposure is the amount of a substance that an individual can be

exposed to daily over a lifetime without resulting in an appreciable toxic effect.

ADI Acceptable Daily Intake is the amount of a substance in food or drinking water that can

be ingested daily over a lifetime without an appreciable health risk.

Approved

Handler

A person who holds a current test certificate certifying that the person has met the

requirements of Hazardous Substances and New Organisms (Personnel Qualifications)

Regulations 2001 in relation to an approved handler for 1 or more hazard classifications

or hazardous substances.

Benefit The value of a positive effect expressed either in monetary or non-monetary terms.

Chronic Adverse effect that occurs after a repeated exposure and which usually are long lasting

and recurring.

Cost The value of an adverse effect expressed either in monetary or non-monetary terms.

Endpoint Toxicological or ecotoxicological value used in the risk assessment

Exposure Human or environmental organism contact with a substance.

GAP Good Agricultural Practice. GAP is an internationally recognised food safety tool for

describing best practice for safe and effective chemical use.

HSNO The Hazardous Substances and New Organisms Act 1996.

IPM Integrated Pest Management involves the careful use of pest control techniques to

discourage the development of pest populations and minimises the use of pesticides.

Likelihood The probability of an effect occurring.

Magnitude Expected level of effect.

MRL Maximum Residue Limits restrict the quantity of a given chemical remaining on food

product samples, which is acceptable in a specific market.

PDEfood The Potential Daily Exposure for food is the amount of a substance in food which may be

ingested daily over a lifetime without resulting in an appreciable toxic effect.

Phytosanitary Relates to the health of plants, especially with respect to the requirements of

international trade.

PPE Personal Protective Equipment including any item of equipment used to protect a person

from hazards e.g. safety helmet, goggles, gloves, boots, respirator.

REI

A Restricted Entry Interval is the time which must elapse after application of a substance

before entry into the treated area is permitted without use of PPE or Respiratory

Protective Equipment.

RPE Respiratory Protective Equipment (a type of PPE).

Risk The combination of the magnitude of an adverse effect and the probability of its

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occurrence.

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June 2013

Annex: Controls for OPC plant protection insecticides

A full list of controls for each substance that has been approved in this decision is set out in an

accompanying annex. The Controls Annex can be found on the EPA’s website.

Documents

Application for the Reassessment of a Group of … 400EC HSR000956 Page 10 Decision on the Application for reassessment of OPC plant protection insecticides (APP201045) June 2013 Fenafos